Reported trial results for Pulmonary Hypertension

133 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT04175600 · results posted 20 July 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04175600) enrolled 138 people with pulmonary arterial hypertension (a condition where blood pressure in the arteries supplying the lungs is abnormally high) — 69 received a placebo (dummy treatment) and 69 received a medicine called selexipag. The trial was primarily measuring how long it took for participants' condition to get worse, defined by specific events such as death, being added to a lung transplant waiting list, being hospitalised due to worsening disease, or other signs of clinical decline. The reported data shows that for the placebo group, the estimated median time to one of those disease progression events was approximately 35.3 months; for the selexipag group, this figure was listed as "not available" (NA) in the submitted data, meaning a median could not be calculated from the reported figures — this was not reported rather than being a missing error. For a secondary measure — a blood marker called NT-proBNP (a protein released when the heart is under strain, where a lower ratio suggests less strain) — the reported ratio of the Week 24 level compared to the starting level was 1.05 in the placebo group and 0.98 in the selexipag group, meaning levels were broadly similar at that time point across both groups. Regarding adverse events (unwanted medical occurrences during the trial), the reported data shows that 65 of 69 placebo participants and 68 of 69 selexipag participants experienced at least one adverse event; serious adverse events were reported in 26 placebo participants and 32 selexipag participants. Thirteen placebo participants and 9 selexipag participants stopped treatment early due to an adverse event. Small changes in blood pressure and pulse rate across various time points were also recorded as secondary measures, with the reported figures varying modestly between the two groups at different time points — the data did not show a consistent or large difference in either direction between the groups for these physical measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04084678 · results posted 6 July 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04084678) enrolled 10 participants in total — 8 received ralinepag and 2 received a placebo (a dummy treatment with no active ingredient). The trial was measuring a specific aspect of exercise capacity called "peak VO2," which is the maximum amount of oxygen the body can use during intense exercise, tested using a specialised exercise test (called a CPET, or cardiopulmonary exercise test). This measurement was taken at the start of the trial and again after 28 weeks to see how it changed. The reported data shows that, on average, participants in the ralinepag group had a change of **−1.953 mL/kg/min** in their peak VO2 from the start to week 28 — meaning the average figure went down slightly over the course of the trial. Participants in the placebo group had an average change of **+0.929 mL/kg/min**, meaning their average figure went up slightly. It is also worth noting that 6 of the 8 participants in the ralinepag group did not complete the trial, while both placebo participants did complete it. No secondary outcome data was reported in the submitted results. It is important to note that this was a very small trial, and the data as submitted does not include fuller context such as why participants left early. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05975905 · results posted 2 July 2026

  According to the results reported on ClinicalTrials.gov, this trial tested an investigational treatment called KER-012 in people with pulmonary arterial hypertension (a condition where the blood pressure inside the lungs is abnormally high). Participants were already receiving standard background treatment for the condition. A total of 113 people took part across four groups — 24 in Arm 1 (placebo), 25 in Arm 2, 25 in Arm 3, and 39 in Arm 4 — over a 24-week treatment period, with a further extension phase planned. The trial was primarily looking at changes in pulmonary vascular resistance (a measure of how hard it is for blood to flow through the lungs' blood vessels), as well as several secondary measures including walking distance, heart function rating, and a blood marker linked to heart stress. The reported data shows that, after 24 weeks, the placebo group (Arm 1) had an average change in pulmonary vascular resistance of −15.3 units, while Arms 2, 3, and 4 had average changes of −73.0, −81.0, and −47.8 units respectively (lower numbers indicate reduced resistance). For the six-minute walking distance test — a standard way of gauging how far someone can walk in six minutes — the reported average changes were +13.3 metres for the placebo group, +5.3 metres for Arm 2, −7.5 metres for Arm 3, and +3.0 metres for Arm 4. Regarding the heart function class rating, the number of participants who showed improvement or stable good function was 15 in the placebo group, 6 in Arm 2, 7 in Arm 3, and 14 in Arm 4. For the blood stress marker (NT-proBNP), the reported average changes were 0.0, −35.5, −4.0, and −7.0 units for Arms 1 through 4 respectively. Notably, a large proportion of participants did not complete the treatment period across all groups, and no participants completed the extension phase, so these figures reflect only those who reached the 24-week point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04266197 · results posted 17 June 2026

  According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called RT234 across 42 participants in total, split into three groups based on dose level: 7 people received the 0.5 mg dose, 21 received the 1.0 mg dose, and 14 received the 2.0 mg dose. All 42 participants completed the study. The trial was measuring how RT234 might affect the body's ability to use oxygen during exercise, as well as how efficiently the lungs work, and how much breathlessness and physical effort participants reported during a supervised exercise test (called a cardiopulmonary exercise test, or CPET). The reported data shows that the main thing being measured — the change in how much oxygen the body uses at peak exercise — showed small increases across all groups. Overall, the average (mean) change was +0.36 millilitres of oxygen per kilogram of body weight per minute, and the middle value (median) across all participants was +0.40. The 2.0 mg group showed the largest average increase (+0.55), while the 0.5 mg group's median value was slightly negative (−0.80). For the breathing efficiency measure, the reported data shows an overall average reduction of −1.85 units across all participants, with the 2.0 mg group showing the largest reduction (−3.38). For reported breathlessness, participants across all groups reported lower scores after dosing, with an overall change of −1.3 points on a 0–10 scale. For reported effort during exercise, the overall change was −1.0 on a 6–20 scale, though the 2.0 mg group reported no change (0). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04811092 · results posted 27 April 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04811092) enrolled 321 adults with pulmonary arterial hypertension (PAH) — a condition affecting blood pressure in the lungs. Around 161 people were assigned to receive sotatercept alongside their usual PAH medicines, and 160 received a placebo (a dummy treatment) alongside their usual PAH medicines. The trial's main goal was to measure how long it took before participants experienced a significant health setback, such as hospitalisation, a procedure, or death — referred to as "clinical worsening." The reported data shows that for the primary measure — the middle point (median) time until a clinical worsening event — the sotatercept group's figure was listed as "not available/not reached," meaning more than half of participants in that group had not experienced such an event by the time the data were collected. In the placebo group, that middle-point time was reported as 23 months. For the secondary measures at 24 weeks: approximately 29% of the sotatercept group met a combined improvement target (covering walking distance, a heart-stress blood marker called NT-proBNP, and symptom class) compared with about 15% in the placebo group. Around 60% of the sotatercept group maintained or reached a "low risk" score on a disease management tool (REVEAL Lite 2), versus about 48% in the placebo group. The median change in the NT-proBNP blood marker was a reduction of roughly 199 units in the sotatercept group compared with a reduction of about 10 units in the placebo group. Roughly 55% of the sotatercept group either improved or stayed at a stable symptom level, compared with about 39% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05339087 · results posted 21 January 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people in total — 17 received riociguat and 18 received a placebo (a dummy treatment with no active ingredient). The trial ran for 24 weeks and was designed to measure changes in how blood flows through the lungs, as well as exercise capacity and breathing function. By the end of the study, 16 participants in each group had completed the trial. The reported data shows that the main thing being measured was a value called Pulmonary Vascular Resistance (PVR) — essentially the resistance the heart faces when pumping blood through the lungs. In the riociguat group, this figure changed by −0.69 units (a decrease), while in the placebo group it changed by +0.89 units (an increase). On a secondary measure of how much blood the heart pumps per minute relative to body size (Cardiac Index), the riociguat group showed a change of +0.21 and the placebo group −0.07. For the 6-minute walking distance test — how far participants could walk in six minutes — both groups showed very similar changes: the riociguat group changed by 23 metres and the placebo group by 24 metres. Changes in lung diffusion capacity (how well the lungs transfer oxygen into the blood) were also reported: +1.16% predicted in the riociguat group and +0.09% in the placebo group. The trial notes that formal step-by-step testing of the secondary measures was stopped after the first step, so those additional results should be interpreted with that in mind. For the WHO Functional Class — a rating system where Class I is the mildest and Class IV the most severe form of pulmonary hypertension — the reported data shows that in the riociguat group, 2 participants improved their class, 0 worsened, and 14 stayed the same; in the placebo group, 3 improved, 1 worsened, and 12 stayed the same. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05764265 · results posted 26 December 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05764265) enrolled 31 people in total — 23 who received the active treatment (LTP001 6 mg) and 8 who received a placebo (an inactive look-alike). The trial was studying LTP001 as a potential treatment for pulmonary hypertension (a condition involving high blood pressure in the arteries of the lungs). It was designed to run for up to 52 weeks, but the study was terminated early, meaning no participant completed the full planned duration. The main thing being measured was how many participants experienced adverse events (unwanted health changes) and serious adverse events during the trial. Several secondary measurements looked at changes in heart and lung blood-flow readings taken via a procedure called right heart catheterisation — a test that directly measures pressures and flow inside the heart and lungs. The reported data shows that, for the primary measure of adverse events, 52.2% of participants in the active treatment group and 62.5% in the placebo group experienced at least one adverse event. Serious adverse events were reported in 17.4% of the active treatment group and 0% of the placebo group. For the secondary measurements taken at around 26 weeks, the reported data shows small changes from starting values across both groups in several heart and lung pressure readings. For example, average pulmonary artery pressure changed by +3.8 mmHg in the active treatment group and −1.5 mmHg in the placebo group. Pulmonary vascular resistance (a measure of how hard it is for blood to flow through the lung arteries) changed by +100.1 units in the active treatment group and −7.4 units in the placebo group. Other measures — including cardiac output, wedge pressure, and right atrium pressure — showed only small numerical differences between the two groups, as reported. It is important to note that because the trial ended earlier than planned, the results are based on a small number of participants and do not cover the full study period originally intended. The reasons for early termination were not detailed in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05564637 · results posted 3 December 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total — 23 patients with a condition called PAH-ILD (a combination of pulmonary arterial hypertension and interstitial lung disease) and 1 healthy volunteer for comparison. Of those, 22 PAH-ILD patients and the 1 healthy volunteer completed the study. The trial was measuring how the heart and lungs perform during exercise, using a procedure called right heart catheterisation (a thin tube inserted into the heart to take direct measurements). The main thing being measured was "cardiac output reserve" — essentially how much extra pumping capacity the heart has when going from rest to exercise. The reported data shows that PAH-ILD patients had a cardiac output reserve of 3.3 litres per minute, compared to 3.8 litres per minute in the healthy volunteer. For breathing efficiency (a measure of how much air a person needs to breathe out for every unit of carbon dioxide produced), the reported figures were 50.4 for PAH-ILD patients and 51.2 for the healthy volunteer — higher numbers suggest less efficient breathing. Blood pressure in the lung arteries at rest was reported as 36.0 mmHg in PAH-ILD patients and 25.1 mmHg in the healthy volunteer. Resistance to blood flow through the lung blood vessels was reported as 5.4 units at rest and 4.3 units during exercise for PAH-ILD patients, compared to 3.1 at rest and 2.2 during exercise for the healthy volunteer. For heart failure symptom severity (scored on a scale of I to IV, where higher means more severe), the reported data shows that among PAH-ILD patients, 1 was in Class I, 9 in Class II, 6 in Class III, and 6 in Class IV; comparable breakdown data for the healthy volunteer was not reported separately in the dataset. It is worth noting that because only one healthy volunteer took part, the comparison figures for that group should be interpreted with great caution, and the trial was very small overall. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03648385 · results posted 5 November 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03648385) enrolled 26 adults in total — 14 in one group and 12 in the other — and all 26 completed the study with no dropouts. It was a crossover design, meaning one group took DHEA (a hormone supplement) first and then switched to a placebo, while the other group did the reverse. The trial was measuring how the right side of the heart — the chamber that pumps blood to the lungs — functioned over time, using specialised heart MRI scans. The key things being tracked were how well the right heart muscle stretches and squeezes (called "strain"), how much blood the chamber holds when full and when empty (called end-diastolic and end-systolic volume), and how efficiently it pumps (called ejection fraction, meaning the percentage of blood pumped out with each beat). The reported data shows the following measured values across both groups and time points. For longitudinal strain (how much the muscle shortens lengthwise — where more negative numbers indicate greater shortening), readings ranged from around −16.7% to −18.3% across baseline, 18 weeks, and 40 weeks in both groups. For radial strain (how much the muscle thickens outward — where positive numbers are normal), values ranged from approximately 19.1% to 23.1% across the same time points. For circumferential strain (squeezing around the chamber), figures ranged from about −12.3% to −14.4%. The reported data shows right ventricular blood volume when full (end-diastolic volume) ranged from roughly 156.7 mL to 173.8 mL at baseline, and from approximately 159.8 mL to 161.4 mL at later time points. Blood volume when empty (end-systolic volume) ranged from about 73.6 mL to 86.6 mL at baseline and 74.2 mL to 81.1 mL at later time points. The pumping efficiency (ejection fraction) ranged from approximately 49.2% to 52.6% across all groups and time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02932410 · results posted 12 September 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT02932410) enrolled 165 children and young people with pulmonary arterial hypertension (PAH) — a condition affecting blood pressure in the lungs. Participants were divided into four groups based on age and treatment: those aged 2 years and over who received macitentan (73 participants), those aged 2 and over who received standard of care (75 participants), those under 2 years old who received macitentan (9 participants), and a separate group of 8 teenagers aged 12 to under 18 from China who also received macitentan. The trial was primarily measuring how much of the study drug (macitentan) and its breakdown product (aprocitentan) could be detected in participants' blood at specific time points — this is a way of understanding how the body processes the medication. The reported data shows the levels of macitentan and aprocitentan measured in the blood (in nanograms per millilitre, which is simply a unit for measuring tiny amounts of a substance in liquid). For children aged 2 and over receiving macitentan, blood levels of macitentan at week 12 ranged across different weight and age groups from approximately 150 to around 1,165 nanograms per millilitre, and aprocitentan levels ranged from roughly 154 to around 1,011 nanograms per millilitre. For children under 2 years old, blood levels measured at week 4 were reported as approximately 102 nanograms per millilitre for macitentan and 707 nanograms per millilitre for aprocitentan. For the Chinese teenage group, the reported week 12 levels were approximately 202 nanograms per millilitre for macitentan and 1,314 nanograms per millilitre for aprocitentan. The trial also listed two secondary outcomes — time to disease getting worse, and time to hospital admission related to PAH — however, the results data for these two measures was not reported on ClinicalTrials.gov, so no numbers are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04896008 · results posted 22 August 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04896008) enrolled 172 people with pulmonary arterial hypertension (PAH — a condition involving high blood pressure in the arteries of the lungs), with 86 assigned to receive sotatercept and 86 assigned to receive a placebo (an inactive treatment used for comparison). The trial's main goal was to measure how long it took before a participant experienced a serious illness-related event or death — specifically, death from any cause, a lung transplant, or a hospital stay of at least 24 hours due to worsening PAH. By the end of the study, 69 people in the sotatercept group and 60 in the placebo group had completed the trial. The reported data shows that for the primary outcome — time to a first serious event — the median time (the point by which half of participants had experienced such an event) was reported as 9.6 months for the placebo group. A median figure for the sotatercept group was not reported in the submitted data, which can occur when fewer than half of participants in that group experienced such an event during the study period. For deaths specifically, 12.8% of participants in the sotatercept group and 16.3% in the placebo group were reported to have died during the study. The reported data for overall survival and transplant-free survival (time without needing a transplant or dying) did not include median values for either group — these were listed as not available in the submitted results. The reported data also shows results from a risk scoring tool called REVEAL Lite 2.0, which uses a scale of 1 to 14 to estimate a patient's risk level (lower scores meaning lower risk). At 24 weeks, the sotatercept group's median score changed by minus 3.0 points from their starting score, compared with minus 1.0 points in the placebo group. Additionally, 48.7% of participants in the sotatercept group and 14.3% in the placebo group were reported to have reached a low or intermediate risk score (7 or below) at the 24-week mark. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03122730 · results posted 31 July 2025

  According to the results reported on ClinicalTrials.gov, this trial investigated a medicine called VentaProst in people with a condition affecting blood pressure in the lungs (pulmonary hypertension). The trial had two parts. In Part 1, nine participants were enrolled and seven completed that stage. In Part 2, eight participants started and all eight completed. The trial was measuring what dose of VentaProst would produce a similar body response (changes in blood flow and pressure readings) to an existing standard treatment called epoprostenol. The reported data shows that in Part 1, a VentaProst dose of 17 nanograms per kilogram per minute (a standard way of measuring how much medicine is given relative to a person's body weight) was the dose that matched the body response seen with the standard treatment. In Part 2, the trial tested a range of doses — 6.8, 10.2, and 13.6 nanograms per kilogram per minute — and measured blood flow and pressure readings at each level to identify which dose produced the most favourable pattern of those readings. The reported data does not include a single summarised result for Part 2 beyond listing these three dose levels that were examined. It is worth noting that the trial was a small, early-stage study focused on finding a comparable dose, not on drawing broad conclusions about the medicine's overall value. The numbers above simply reflect what was measured and recorded for this specific group of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05135000 · results posted 15 May 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05135000) enrolled 47 people in total — 35 received a treatment called LTP001 and 12 received a placebo (a dummy treatment with no active ingredient). The trial was studying people with pulmonary hypertension, a condition involving high blood pressure in the lungs. The main thing researchers were measuring was a change in something called pulmonary vascular resistance (PVR) — essentially, how much resistance there is to blood flowing through the lungs — after 25 weeks. A number of other measurements were also taken, including how far participants could walk in six minutes, and various pressures inside the heart and lungs. By the end of the study, 26 people in the LTP001 group and 9 in the placebo group had completed the trial. The reported data shows that for the main outcome — change in pulmonary vascular resistance at week 25 — the LTP001 group had a change of −1.175 units (dynes.sec.cm⁻⁵), while the placebo group had a change of −49.685 units. For the six-minute walk distance, the reported data shows changes across two time points, though the specific timepoints were not clearly labelled in the data provided: in the LTP001 group the changes were +3.2 metres and +10.4 metres, compared with +7.4 metres and +21.0 metres in the placebo group. For the other heart and lung pressure measurements at week 25, the reported changes were small in both groups: right atrium pressure changed by −0.4 mmHg (LTP001) versus −0.6 mmHg (placebo); pulmonary capillary wedge pressure changed by +0.2 mmHg versus +0.9 mmHg; mean pulmonary artery pressure changed by +0.4 mmHg versus −0.6 mmHg; and average cardiac output (how much blood the heart pumps per minute) changed by +0.067 litres per minute versus +0.493 litres per minute. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04271475 · results posted 22 April 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04271475) enrolled 127 people in its main double-blind phase — 64 received macitentan and 63 received a placebo (a dummy treatment). The trial was examining whether macitentan made a difference for people with a specific lung condition, using several measurements including how far participants could walk in six minutes, how long it took for their condition to worsen, how they rated their symptoms, and their overall quality of life. A small number of participants (7 in total) continued into an open-label phase where everyone received the active treatment, but very few completed either phase of the study. The reported data shows that for the primary measurement — the change in how far participants could walk in six minutes after 28 weeks — those in the macitentan group walked an average of 9.7 metres more than their starting distance, while those in the placebo group walked an average of 25.8 metres more than their starting distance. For the secondary measurements, 7 participants in the macitentan group and 6 in the placebo group showed an improvement in their functional class (a rating of how much their condition limits daily activity). Small reductions in symptom scores were reported in both groups across the cardiopulmonary and cardiovascular symptom scales, with the macitentan group showing slightly larger reductions. On the quality-of-life measures, the macitentan group reported slightly larger improvements than the placebo group in both the utility score and the visual scale rating of current health. The data for the time-to-worsening outcome was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04732221 · results posted 21 February 2025

  According to the results reported on ClinicalTrials.gov, this trial tested an inhaled investigational medicine called MK-5475 in people with pulmonary arterial hypertension (PAH) — a condition where the blood pressure in the arteries supplying the lungs is abnormally high. The trial had two phases: a base period, where 168 participants were randomly assigned to receive either a placebo (dummy treatment) or one of three doses of MK-5475 (32, 100, or 380 micrograms), and an extension period, where a further 135 participants received one of the three doses. The trial was measuring, among other things, changes in the resistance to blood flow through the lungs (called pulmonary vascular resistance, or PVR) and how far participants could walk in six minutes — a standard way of gauging physical capacity. The reported data shows that after 12 weeks in the base period, the placebo group's PVR went up by an average of 4.3%, while the three MK-5475 dose groups saw average reductions of 4.9%, 17.6%, and 15.6% respectively. For the six-minute walk test in the base period, the reported data shows that all four groups walked further on average than they had at the start: the placebo group improved by about 24.6 metres, the 32-microgram group by 27.4 metres, the 100-microgram group by 10.8 metres, and the 380-microgram group by 11.3 metres. For the secondary measures of heart function — pressure in the right side of the heart, the heart's pumping efficiency, and the volume of blood pumped per heartbeat — the reported changes across all groups were small. The six-minute walk distance results for the Phase 3 part of the trial were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05337943 · results posted 27 January 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled a very small number of participants — just 6 people in total. They were divided across three groups: one person received Cognitive Behavioural Therapy for Insomnia (CBT-I, a structured talking-based approach to sleep problems), three people received Bright Light Therapy (exposure to a specially designed light source), and two people received Standard Care. The trial was measuring whether participants stayed in the study and completed all of the required procedures — this is called a "retention rate," and is often used in small early-stage trials to check whether a study design is practical to run. The reported data shows that of the 6 people who started the trial, only 3 completed all study procedures. Breaking this down by group: none of the 1 participant in the CBT-I group completed the study, 1 out of 3 participants in the Bright Light Therapy group completed it, and both participants (2 out of 2) in the Standard Care group completed it. No other outcome measures were reported in the submitted data beyond this completion count. It is worth noting that this was an extremely small trial — just 6 people across all three groups — and only one outcome measure was reported. Any figures from a group of this size are very limited in what they can tell us. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03576885 · results posted 15 January 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03576885) enrolled 32 participants in total — 16 in the active treatment group and 16 in the placebo group. A third "control group" was listed but had no participants. All 32 participants who started the study completed it. The trial was measuring outcomes in what appears to be a newborn or infant population, looking at three main things: death, a lung condition called bronchopulmonary dysplasia (BPD — a breathing problem that can develop in premature babies, identified by the need for breathing support or extra oxygen), and high blood pressure in the lungs (pulmonary hypertension). The reported data shows the following numbers. For deaths, 1 participant in the active treatment group and 1 participant in the placebo group passed away during the study. For bronchopulmonary dysplasia, 10 out of 16 participants in the active treatment group and 9 out of 16 in the placebo group were recorded as having the condition. For pulmonary hypertension — which was checked every one to two days after joining the study — 11 out of 16 participants in the active treatment group and 15 out of 16 in the placebo group were recorded as having this outcome. It is worth noting that the data as submitted does not include any further statistical analysis or comparison figures beyond these raw counts, so no additional numbers are available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03451630 · results posted 9 December 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,400 people across three groups: a "High-Touch" group (562 people, meaning more personal, face-to-face support after leaving hospital), a "High-Tech" group (552 people, meaning technology-based support), and an "Optimal Discharge Planning" group (286 people, receiving a structured planning approach). The trial was measuring how well each approach supported people after a hospital stay, looking at things like how confident people felt managing their own health, their general health status, their physical function, quality of life, and how many people were re-admitted to hospital within 30 and 90 days of discharge. The reported data shows that scores on the patient confidence and knowledge measure (rated 0–100, where higher is better) sat in a similar range across all three groups throughout the study, roughly between 62 and 65 out of 100. General health status scores (also 0–100) were reported in the low 40s for all groups at most time points, up from around 39–40 at the start. Physical function scores and quality-of-life scores were also closely matched across the three groups at all time points. For hospital readmissions, the reported data shows that out of those who were followed up over 90 days, 85 people in the High-Touch group, 71 in the High-Tech group, and 41 in the Optimal Discharge Planning group were readmitted. Over 30 days, the numbers were 24, 17, and 11 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02587325 · results posted 25 November 2024

  According to the results reported on ClinicalTrials.gov, this was a Phase 1 dose-finding trial testing a drug called nab-sirolimus in people with a serious lung condition affecting blood pressure in the lungs (pulmonary arterial hypertension). A total of 15 people took part across five dose groups (cohorts), with 3–4 people in most groups and 1 in the smallest group. The trial had two parts: a main 16-week treatment period, and an optional 32-week extension. The main goal was to find out how many participants in each dose group experienced a "dose-limiting toxicity" — meaning a serious side effect serious enough to require reducing or stopping the dose within the first four weeks. The reported data shows that zero participants across all five dose cohorts experienced a dose-limiting toxicity during the first four weeks of treatment. For the secondary measurements — things tracked to get a broader picture — the trial looked at changes from the start of the study to Week 17. One heart function measure (pulmonary vascular resistance, which reflects how hard the heart has to work to push blood through the lungs) showed a reported overall median change of −20.5%, meaning on the whole the group's readings were lower at Week 17 than at the start; individual cohort figures ranged from −30.8% to +10.9%. A walking test (how far participants could walk in six minutes) showed an overall reported median change of +15.0%, with individual cohort figures ranging from −2.0% to +21.0%. A blood marker linked to heart strain (NT Pro-BNP) showed an overall reported median change of −19.3%, with individual cohort figures ranging from −49.0% to −7.1%. The reported data also included cardiac output figures, though those results showed mixed directions across cohorts. It is important to note that this was a very small, early-stage trial designed primarily to explore dosing and monitor for certain side effects — not to draw firm conclusions about how the drug performs. The numbers above simply describe what was measured and recorded; they do not tell us what would happen in a larger group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03950739 · results posted 1 November 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people who had been using an inhaled medicine called Tyvaso (inhaled treprostinil) and then switched them to a different device for delivering the same medicine, called TreT. The trial was measuring three main things: how far participants could walk in six minutes, how satisfied they were with the new device compared to the old one, and how they rated their own pulmonary arterial hypertension (PAH — a condition affecting blood pressure in the lungs) symptoms and their impact on daily life. Of the 51 who started the main treatment phase, 49 completed it, and 49 then went on to an optional extension phase, of whom 31 completed that. The reported data shows that, on average, participants walked approximately 11.5 metres further in the six-minute walk test after three weeks on the new TreT device compared to when they started. Regarding device satisfaction, the reported data shows that out of those who responded, 40 participants chose "strongly agree," 5 chose "agree," 1 chose "neutral," and none chose "disagree" or "strongly disagree" across the satisfaction statements. For self-reported symptoms and daily impact, scores were measured on a scale of 0 to 4 (where higher means worse). The reported data shows small reductions (improvements) in scores across four areas — cardiopulmonary symptoms, cardiovascular symptoms, physical impact, and emotional/cognitive impact — at both three weeks and eleven weeks, with changes ranging from around −0.04 to −0.20 on the scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03617458 · results posted 16 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03617458) enrolled 73 people across four groups: one group received metformin (a medicine) combined with an mHealth intervention (a digital/mobile health support tool); a second received a placebo (a dummy treatment) combined with usual care; a third received metformin with usual care; and a fourth received a placebo with the mHealth intervention. The trial ran for 12 weeks and was primarily measuring two things: how far participants could walk in six minutes, and whether their World Health Organization (WHO) Functional Class — a rating of how much symptoms affect day-to-day life — changed over that period. The reported data shows that, for the six-minute walk test, the distances recorded across the four groups at the start of the study ranged from roughly 415 to 483 metres, and at week 12 ranged from roughly 455 to 486 metres. For the WHO Functional Class measure, the reported data shows the number of participants whose classification stayed the same or changed. In the metformin plus mHealth group, 15 out of 15 completers had no change in class and 1 did change; in the placebo plus usual care group, 12 had no change and 2 changed; in the metformin plus usual care group, 14 had no change and 3 changed; and in the placebo plus mHealth group, 13 had no change and 5 changed. For the secondary outcomes — including changes in body weight, BMI, absolute six-minute walk distance, and the Borg dyspnea score (a rating of how hard breathing feels during activity) — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05557942 · results posted 10 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT05557942) involved 186 participants across six groups. Some participants had previously received a placebo and then switched ("crossed over") to one of three doses of a medicine called AV-101 (10 mg, 35 mg, or 70 mg), while others continued on AV-101 at those same doses throughout. The trial was measuring the number of participants who experienced what are called "treatment-emergent adverse events" — that is, any unexpected medical occurrence that happened after receiving the study drug, regardless of whether it was thought to be caused by the drug. The reported data shows that in the three crossover groups, 9 out of 18 participants in the 10 mg group, 11 out of 18 in the 35 mg group, and 12 out of 16 in the 70 mg group experienced at least one such medical occurrence. In the groups who continued on AV-101, the reported data shows 26 out of 45 participants in the 10 mg group, 25 out of 48 in the 35 mg group, and 21 out of 41 in the 70 mg group experienced at least one such occurrence. It is worth noting that the data shows zero participants were recorded as having "completed" the study across all six groups, though no further explanation for this was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03015402 · results posted 7 June 2024

  According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called oral nitrite in people with a condition affecting blood pressure in the lungs (pulmonary hypertension related to heart failure). It was a "crossover" trial, meaning participants took both the nitrite treatment and a dummy treatment (placebo) at different times, in random order, with a two-week break in between. A total of 24 people were enrolled across two groups — 13 started with nitrite first, and 11 started with placebo first. By the end of the study, 21 people completed both treatment periods. The reported data shows that the main thing being measured was blood pressure inside the lung's main artery (called mean pulmonary artery pressure, measured in mmHg — millimetres of mercury, a standard unit for blood pressure) during moderate exercise. After 10 weeks, the reported average pressure was 48.75 mmHg for the nitrite group and 48.68 mmHg for the placebo group — figures that were very close to each other. Baseline (starting) readings before each treatment period were also reported as 56.81 mmHg and 55.0 mmHg respectively. For the secondary measurements, the reported data shows that the distance walked in six minutes averaged 269.5 metres on nitrite and 267.6 metres on placebo (baseline: 253.2 and 255.2 metres). A blood marker sometimes used to track heart strain (NT-proBNP) was reported at 4,146 pg/ml on nitrite and 4,215 pg/ml on placebo, though not all participants had this measured. Other heart and lung pressure readings from a specialised heart test were also reported across both groups, with figures that were broadly similar between the two treatments. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03542812 · results posted 2 May 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03542812) enrolled 16 premature infants considered at high risk of developing a lung and blood pressure condition called BPD-PH. Participants were split into two groups: 10 infants in a "single-dose" group (who received one dose of an oral supplement called L-citrulline) and 6 infants in a "steady-state" group (who received doses every 6 hours over 72 hours, for 12 doses total). All 16 participants completed the trial. The trial was measuring how L-citrulline levels in the blood changed over time after dosing, whether a target blood level could be reached with repeated dosing, and tracking certain events such as feeding interruptions and drops in blood pressure. The reported data shows that in the single-dose group, the average L-citrulline level in the blood before dosing was 31 micromol/L (a unit measuring the concentration of a substance in the blood). After a single dose, levels rose — reaching around 470 micromol/L at 15 minutes and 651 micromol/L at 1 hour — before falling back to approximately 232 micromol/L at 2.5 hours and 197 micromol/L at 3 hours. In the steady-state group, the reported data shows the average blood level before the first dose was 37.5 micromol/L, and just before the final (12th) dose it was 38 micromol/L — notably, this did not reach the study's target range of approximately 50–80 micromol/L. For the secondary outcome in the steady-state group, a urine measure of nitric oxide-related substances (molecules linked to blood vessel function) was 25.8 units at baseline and 36 units after the last dose. Regarding the tracked events: no participants in either group had their feedings stopped for reasons unrelated to their underlying condition. One participant in the steady-state group was reported to have experienced a significant drop in blood pressure; no participants in the single-dose group had this recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04370873 · results posted 26 April 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04370873) looked at an investigational inhaled medicine called MK-5475 in two separate parts. In Part 1, nine people took part over seven days — six received MK-5475 at a dose of 360 micrograms and three received a placebo (an inactive substance used for comparison). In Part 2, thirteen people took part over twenty-eight days — eight received MK-5475 at a slightly higher dose of 380 micrograms and five received a placebo. All participants in both parts completed their assigned dosing period. The trial was primarily measuring how often participants experienced any unwanted medical events (called "adverse events") and whether any of these events led someone to stop taking the study drug. It also measured a reading called pulmonary vascular resistance — essentially the amount of resistance to blood flow through the lungs — in Part 2. The reported data shows that in Part 1, 33.3% of participants in both the MK-5475 group and the placebo group reported at least one adverse event. In Part 2, 33.3% of participants in the MK-5475 group reported at least one adverse event, compared with 80.0% in the placebo group. Importantly, the reported data shows that no participants in any group — across either part of the trial — stopped taking the study drug because of an adverse event. Regarding the pulmonary vascular resistance measurement in Part 2, the reported data shows an average reduction of approximately 21.2% from the starting point in the MK-5475 group, compared with a reduction of approximately 5.4% in the placebo group. These are percentage changes on a mathematical scale and were not reported alongside the additional detail needed to draw broader conclusions. The reported data also includes blood-level measurements from Part 1 showing how much of the drug was absorbed into the bloodstream over time and what the peak concentration reached was, though some of these figures appeared to be reported at two separate time points (Day 1 and Day 7) rather than as a single combined figure. No secondary outcome data was reported for Part 2 participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03044314 · results posted 2 April 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 27 people, all of whom received both inhaled nitric oxide and a drug called iloprost. These are medicines that cause blood vessels to relax, and the trial was measuring how blood pressure in the lungs (pulmonary artery pressure) changed after each one was given. Twenty-three participants completed the trial, and four did not finish. The reported data shows that, on average, lung blood pressure dropped by about 10.7% after inhaled nitric oxide was given, and by about 13.3% after iloprost was given — these are the figures for the primary (main) outcome, which was the percentage change in pressure measured directly inside the blood vessels. For a secondary (additional) outcome looking at a specific measure called systolic pulmonary arterial pressure (the peak pressure in the lung vessels during a heartbeat), the reported change was 0%. When the trial looked at how many participants met a pre-set definition of a "responder" — meaning their lung pressure dropped by at least 10 mmHg and fell below 40 mmHg — the reported data shows 1 out of the group responded to inhaled nitric oxide and 4 responded to iloprost. For the outcome measuring responses picked up by ultrasound of the heart (echocardiography), the reported count of responders was zero across all recorded time points. The outcome looking at whether pressure changes were linked to longer-term events such as hospital admissions or death was listed in the trial but no numerical data was reported for it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02261883 · results posted 5 March 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02261883) enrolled 42 newborns or young patients in total — 21 received an intravenous medication called Remodulin (treprostinil), and 21 received a placebo (an inactive treatment). The trial was measuring "clinical worsening," which was defined as any one of three events: death, the need for a life-support machine called ECMO, or the need to start an additional lung-vessel medication. Several secondary measurements were also tracked, including how well the lungs were moving oxygen into the blood (using measures called the Oxygenation Index, P/F ratio, and blood oxygen saturation), a heart-stress marker in the blood (NT-proBNP), and how long it took before clinical worsening occurred. The reported data shows that, for the primary outcome, 8 out of 21 participants in the Remodulin group and 12 out of 21 in the placebo group experienced clinical worsening. Fifteen participants in the Remodulin group and 18 in the placebo group completed the study. For the time-to-worsening measure, the reported median (middle value) was 3.0 days in both groups. For the secondary measures, the reported data shows changes over time in both groups across all the oxygen and blood measures — for example, the Oxygenation Index (a score where higher numbers indicate worse oxygen levels) decreased in both groups across all time points measured, as did the P/F ratio changes and NT-proBNP levels, with the specific numbers varying between groups and time points. The full set of numbers for each time point was reported but individual time-point labels were not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05039086 · results posted 20 February 2024

  According to the results reported on ClinicalTrials.gov, this study looked at Medicare health records in the United States (from January 2008 to December 2018) to compare two groups of people who had been prescribed different types of medication for pulmonary arterial hypertension (a condition affecting blood pressure in the lungs): one group took medicines called PDE5 inhibitors (9,968 people at the start) and the other took medicines called endothelin receptor antagonists (3,053 people at the start). The study's main question was whether there was any difference between the two groups in how quickly people developed dementia — an umbrella term for conditions that affect memory and thinking, including Alzheimer's disease and vascular dementia. Around 2,888 people in each group were counted as having completed the study period being analysed. The reported data shows the main outcome was measured as an "incidence rate" — meaning the number of new dementia cases per 1,000 people observed over one year. Four separate ways of analysing the data were used. In the first analysis, the reported rates were 17.9 (PDE5 inhibitor group) versus 18.8 (endothelin receptor antagonist group) per 1,000 person-years. The second analysis reported 19.8 versus 19.9; the third reported 15.1 versus 22.6; and the fourth, which used a stricter definition of dementia, reported 5.2 versus 4.7. The reported data does not include additional statistical details (such as measures of uncertainty around these figures) that would help interpret how meaningful any of these differences might be. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02587936 · results posted 20 December 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 9,730 people in the Intervention group and 8,538 people in the Usual Care group — a total of over 18,000 participants. The trial was looking at people who had three conditions at the same time: chronic kidney disease, diabetes, and high blood pressure. It was measuring whether an intervention (compared to standard care) was associated with differences in unplanned hospital admissions over 12 months, as well as related events such as readmissions within 30 days. The reported data shows that, for the primary measure — the percentage of participants who had an unplanned hospital stay within 12 months — 20.7% of people in the Intervention group were hospitalised, compared with 21.12% in the Usual Care group. For the secondary measure — the number of people who were readmitted to hospital within 30 days of a prior hospital stay — the reported data shows 429 participants in the Intervention group and 433 in the Usual Care group experienced a readmission. No further breakdown of the many other events listed under the secondary outcome (such as emergency visits, cardiovascular events, or deaths) appears to have been reported in the submitted results data. It is worth noting that a large number of participants did not complete the study — around 4,222 in the Intervention group and 3,046 in the Usual Care group — though the reasons for this were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03904693 · results posted 13 November 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03904693) enrolled 187 participants across three groups during the main double-blind phase (lasting 16 weeks): 35 people received macitentan monotherapy (a single medicine), 44 received tadalafil monotherapy (a single medicine), and 108 received a fixed-dose combination (FDC) tablet containing both medicines together. Participants had pulmonary arterial hypertension (a condition involving high blood pressure in the arteries of the lungs) and were divided based on what treatments, if any, they had previously taken. After the 16-week blinded phase, 169 participants continued into a longer open-label period (where everyone received the combination tablet) lasting up to around week 189. The reported data shows that the primary measure was a change in pulmonary vascular resistance (PVR) — a way of measuring how hard the heart has to work to push blood through the lung arteries, expressed as a ratio comparing end-of-treatment values to starting values (a ratio below 1.0 means the value was lower at the end than at the start). For participants who had previously taken an ERA-type medicine, the reported ratio was 0.77 for the macitentan-alone group and 0.55 for the combination tablet group. For participants who had previously taken a PDE-5i-type medicine, the reported ratio was 0.78 for the tadalafil-alone group and 0.56 for the combination tablet group. For the secondary measure of how far participants could walk in six minutes, the reported average increases from the start of the trial were: 38.5 metres (macitentan alone, prior ERA group), 52.9 metres (combination, prior ERA group), 15.9 metres (tadalafil alone, prior PDE-5i group), and 43.4 metres (combination, prior PDE-5i group). Self-reported symptom scores on a 0–4 scale also showed small reductions (meaning fewer reported symptoms) across all groups, and the majority of participants in each group — roughly 56% to 64% — showed no worsening in their physical activity classification over the course of the double-blind period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04456998 · results posted 7 November 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04456998) involved 86 people in total — 42 received a placebo (an inactive treatment) and 44 received the investigational drug GB002, also known as seralutinib. The trial was looking at a lung condition and measured two main things: changes in pulmonary vascular resistance (PVR) — a measure of how hard the heart has to work to push blood through the lungs, assessed by a procedure that involves a thin tube passed into the heart — and how far participants could walk in six minutes. The reported data shows that, over 24 weeks, the PVR measurement changed by an average of +21.2 units (dyne•s/cm^5) in the placebo group, meaning it went slightly in the less favourable direction, while in the seralutinib group it changed by an average of −74.9 units, meaning it moved in the more favourable direction. For the six-minute walk test, the reported data shows the placebo group walked an average of 7.4 metres further than at the start, while the seralutinib group walked an average of 13.9 metres further than at the start. Of the 44 people who started in the seralutinib group, 38 completed the study and 6 did not; all 42 people in the placebo group completed it. It is worth noting that the data submitted does not include the statistical context (such as whether the differences between the two groups were considered meaningful beyond chance), so those figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03068130 · results posted 12 October 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03068130) enrolled 261 participants, all of whom received a medicine called bardoxolone methyl. The trial was a long-term study, and its main goal was to track and measure any unwanted or unexpected health events (called adverse events) that participants experienced while taking the medicine — including how often these events happened and how severe they were. Notably, the reported data shows that none of the 261 participants were recorded as having completed the study. The reported data shows the following numbers of participants who experienced adverse events, broken down by severity: 232 participants experienced at least one adverse event of any kind. Of these, 89 experienced mild events (meaning symptoms that caused little or no interference with everyday life), 106 experienced moderate events (symptoms that caused more than minimal interference with everyday activities), and 42 experienced severe events (symptoms that made it impossible to carry out usual daily activities). Additionally, 96 participants were reported as experiencing serious adverse events, and 94 participants discontinued the study due to an adverse event. The data does not provide further breakdown beyond these figures. It is important to note that these numbers simply reflect what was recorded and reported — they describe how many people experienced certain health events during the trial, not whether the medicine caused those events or what the overall meaning of these findings is. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04576988 · results posted 23 August 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04576988) enrolled 323 adults with pulmonary arterial hypertension (PAH) — a condition involving high blood pressure in the arteries of the lungs. Participants were split into two groups: 163 people received sotatercept on top of their usual PAH medicines, and 160 received a placebo (a dummy injection) on top of their usual PAH medicines. Neither participants nor their doctors knew which group they were in. The trial measured several things, including how far participants could walk in six minutes, certain markers of heart strain measured in the blood and through a heart procedure, and how many people experienced unwanted medical events during the study. The reported data shows that, after 24 weeks, the sotatercept group's average six-minute walking distance increased by about 34 metres from where it started, while the placebo group's average distance increased by about 1 metre. For a combined measure looking at walking distance, a blood marker of heart strain (called NT-proBNP), and physical functioning together, about 39% of the sotatercept group showed improvement across all three areas, compared with about 10% of the placebo group. The reported data also shows changes in a measure of blood flow resistance in the lungs (pulmonary vascular resistance): the sotatercept group's average reading fell by roughly 165 units, while the placebo group's average rose by about 33 units. The NT-proBNP blood marker fell on average by around 230 units in the sotatercept group and rose by about 59 units in the placebo group. Regarding unwanted medical events, 138 of 163 people in the sotatercept group and 140 of 160 in the placebo group reported at least one such event during the study period; 3 people in the sotatercept group and 10 in the placebo group stopped treatment because of one. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03127852 · results posted 21 August 2023

  According to the results reported on ClinicalTrials.gov, this trial looked at a telemonitoring app called Medly for people living with heart failure. A total of 96 participants took part — 46 in the Medly group and 50 in a control group (who received usual care). The trial's main focus was whether using the app made a difference to participants' overall quality of life, measured using a standard questionnaire called the SF-36, which gives a score from 0 (worst) to 100 (best). A number of secondary measurements were also taken, including hospital and clinic visits, heart-failure-specific quality of life, self-care behaviours, anxiety and depression levels, and how confident participants felt managing their condition. The reported data shows that on the SF-36 overall quality-of-life measure, the Medly group scored 42.77 and the control group scored 42.39 — figures that were very close to each other. For heart-failure-specific quality of life (where a *lower* score means better quality of life), the Medly group reported 35.88 compared to 31.55 in the control group. The reported data shows the Medly group had an average of 1.43 hospitalisations compared to 0.35 in the control group, and 3.71 clinic visits compared to 2.95. On the anxiety scale (0–21, higher means more anxiety), scores were 7.33 for Medly and 5.97 for control; depression scores were very similar at 5.51 and 5.55 respectively. For self-confidence in managing their condition (scored 1–10), the Medly group averaged 7.35 and the control group 6.75. Self-care scores across the three sub-scales were broadly similar between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03689244 · results posted 9 August 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03689244) enrolled 128 participants in total — 64 received a placebo (an inactive treatment) and 64 received a medicine called selexipag. The trial was studying a condition involving the blood vessels in the lungs, and the main thing it was measuring was a value called **pulmonary vascular resistance (PVR)** — essentially, how much resistance there is to blood flowing through the lung's blood vessels. This main measurement was taken at 20 weeks, comparing each participant's reading at that point to their reading at the start of the trial. A smaller number of participants went on to an open-label phase (where everyone received selexipag), but no outcome data from that phase appears in the reported results. The reported data shows the main outcome as a percentage ratio — that is, what the Week 20 reading was compared to the starting reading, expressed as a percentage. A figure of 100% would mean no change; a figure below 100% would mean the reading went down from the start. For the placebo group, the reported figure was **89.52%**, and for the selexipag group it was **85.15%**. In plain terms, both groups showed a lower PVR reading at Week 20 compared to the start of the trial, with the selexipag group's figure being somewhat lower than the placebo group's figure. No secondary outcome measure data was included in the submitted results, so those figures were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03497689 · results posted 7 August 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03497689) enrolled 35 adults who were already receiving treprostinil through an intravenous (into a vein) or subcutaneous (under the skin) injection, and were being transitioned to an oral (tablet) form of the same medicine. Twenty-eight participants completed the study, and seven did not. The main thing the trial was measuring was how many participants could reach a target oral dose of the tablet form of treprostinil by Week 16. The reported data shows that 23 out of 35 participants reached the target oral dose by Week 16. For the secondary measurements — things tracked alongside the main goal — the reported data shows the following changes from the start of the study to the end: participants walked an average of 25 metres more in a standard 6-minute walk test; their shortness-of-breath score (rated 0–10, where lower is better) dropped by an average of 1 point; a protein in the blood linked to heart strain (NT-proBNP) fell by an average of 134 ng/L; and a measure of how much blood the heart pumps per minute (cardiac output) increased by an average of 0.55 L/min. Regarding a standard measure of how much the condition limits daily activity (WHO Functional Class), the reported data shows 19 participants were classified as "improved," 1 as "worsened," and 8 with no change reported in that category. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02657356 · results posted 19 May 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT02657356) enrolled 202 people in total — 102 received placebo capsules (a dummy treatment with no active ingredient) and 100 received bardoxolone methyl capsules. The trial was looking at a lung condition and measured two main things: how far participants could walk in six minutes (known as the six-minute walk distance), and how long it took for participants to show a first meaningful sign of clinical improvement across several health markers, including physical function, kidney function, and a blood marker linked to muscle health. The reported data shows that, at 24 weeks, the placebo group's six-minute walk distance had changed by an average of +9.25 metres from their starting point, while the bardoxolone methyl group's had changed by −3.61 metres (meaning, on average, they walked slightly less far than at the start). For the secondary outcome — time to a first persistent sign of improvement — the reported data shows the placebo group reached that point at an average of 17.9 weeks, while the bardoxolone methyl group reached it at an average of 6.62 weeks. These numbers describe what was measured and recorded; they do not on their own tell us whether any difference between the groups is meaningful without further context from the full study report. It is also worth noting that not everyone finished the trial — 20 people in the placebo group and 15 in the bardoxolone methyl group did not complete it, though the reasons were not detailed in the structured data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03496207 · results posted 19 April 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03496207) looked at a medicine called sotatercept in people with pulmonary arterial hypertension — a condition where the blood pressure in the arteries leading to the lungs is abnormally high. A total of 106 people took part in the main (base) part of the study, split across three groups: 32 received a placebo (a dummy treatment with no active ingredient), 32 received a lower dose of sotatercept (0.3 mg/kg), and 42 received a higher dose (0.7 mg/kg). After the main 24-week period, participants moved into an extension phase lasting up to about two years, where those who had been on placebo were switched to sotatercept, and the others continued on sotatercept. The trial's main measurement was a value called pulmonary vascular resistance (PVR) — essentially a measure of how much resistance there is to blood flowing through the lung arteries, recorded using a procedure called a right heart catheterisation. The reported data shows that at 24 weeks, the average change in PVR from the start of the study was a reduction of 27.6 units (dynes\*sec/cm⁵) in the placebo group, a reduction of 168.4 units in the lower-dose sotatercept group, and a reduction of 258.9 units in the higher-dose sotatercept group. During the extension period, among participants who had originally been on placebo and were then switched to sotatercept, the reported average reduction in PVR from baseline was 246.9 units; among those who had continued on sotatercept throughout, the reported average reduction was 212.6 units. A secondary measure — the six-minute walk test, which records how far a person can walk in six minutes — showed an average increase from baseline of 31.4 metres in the placebo group, 56.0 metres in the lower-dose sotatercept group, and 53.6 metres in the higher-dose sotatercept group at 24 weeks. The reported data also shows that during the extension period, all 15 participants in each placebo-to-sotatercept group and all participants who continued sotatercept experienced at least one adverse event (an unwanted medical occurrence during the study period). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03155373 · results posted 28 February 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 50 participants as a single overall group, with 43 completing the study and 7 not completing it. The trial was measuring how well people's hearts and lungs were functioning after heart surgery, looking specifically at heart pumping ability and exercise capacity. It also examined whether two different types of heart imaging scans agreed with each other, how pre-surgery lung blood pressure measurements compared to a reference standard test, how participants' quality of life changed after surgery, and the amount of scarring (fibrosis) found in heart muscle tissue samples. The reported data shows that 35 out of 50 participants had what the researchers defined as impaired (reduced) heart or exercise function after surgery — meaning their heart pumping function fell below 50% and/or their exercise capacity measured below 84% of what would be predicted for a healthy person their age. For the comparison between two imaging methods (ultrasound of the heart and cardiac MRI), a correlation value — a number between 0 and 1 that reflects how closely two measurements track each other — of 0.31 was reported. For quality of life scores (measured on a survey called the SF-36, where higher scores generally indicate better quality of life), three separate scores of 64.3, 62.9, and 74.9 were reported, though the data does not specify what time points or aspects of quality of life these correspond to. Heart muscle tissue analysis showed fibrosis levels of 8.9%, 8.4%, 3.7%, and 7.4% across different measurements, though the data does not clarify which heart regions these figures relate to. The results for the lung blood pressure accuracy measurement were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02725372 · results posted 25 January 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 157 people in total — 78 in the inhaled nitric oxide group and 79 in the placebo group — across two parts: a blinded treatment phase lasting about 18 weeks, followed by an open-label extension. The trial was studying a condition called pulmonary arterial hypertension (PAH), a type of high blood pressure in the lungs. The main thing being measured was how far participants could walk in six minutes, comparing their distance at the start of the study to their distance at week 18. A number of other things were also tracked, including how long it took before a participant's condition got noticeably worse, changes in a heart-stress marker in the blood, and participants' sense of breathlessness after walking. The reported data shows that, for the main measure — change in six-minute walking distance — the inhaled nitric oxide group's average distance changed by about 4.88 metres, while the placebo group's changed by about 2.89 metres. For the time until a participant experienced a notable worsening event, the reported median was 22 days in the nitric oxide group and 19 days in the placebo group. Regarding improvement in a standard breathing-difficulty rating scale (WHO Functional Class, which runs from Class I with no limitations to Class IV with severe limitations at rest), 2 participants in the nitric oxide group and 1 in the placebo group showed an improvement. A blood marker linked to heart stress (NT-proBNP) changed by an average of 117.8 pg/mL in the nitric oxide group and 207.9 pg/mL in the placebo group. A self-rated breathlessness score immediately after the walk test changed by −0.47 in the nitric oxide group and −0.23 in the placebo group (where a lower number means less breathlessness). Finally, 32 participants in the nitric oxide group and 35 in the placebo group were recorded as having an unsatisfactory clinical response — meaning they remained in a more severe functional class with no improvement in walking distance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02736149 · results posted 18 January 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 51 participants, all of whom received a treatment called Ubenimex. The trial was looking at what are called "treatment-emergent adverse events" — that is, any unwanted or unexpected health events that occurred during the course of taking the treatment. Notably, the reported data shows that none of the 51 participants were recorded as having "completed" the study in the usual sense, and all 51 were listed under "not completed," though no further explanation for this is provided in the submitted data. The reported data shows that out of the 51 participants, 44 experienced at least one treatment-emergent adverse event — meaning an unwanted health event that appeared after they started taking Ubenimex. This was the only outcome measure reported in the submitted results. No other outcome measures, such as measures of how well the treatment worked, appear to have been submitted to ClinicalTrials.gov for this trial, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01342952 · results posted 30 December 2022

  According to the results reported on ClinicalTrials.gov, this trial looked at ambrisentan, a medicine used for a condition affecting blood pressure in the lungs. Participants were assigned to one of four different daily doses — 2.5 mg, 5 mg, 7.5 mg, or 10 mg. A total of 38 people were enrolled across all four dose groups (9, 19, 5, and 5 participants respectively). The trial was primarily focused on tracking medical events that occurred during treatment and monitoring a range of blood test measurements, such as liver enzymes and other chemical markers in the blood. The reported data shows that, looking at unwanted medical events that arose during treatment, the numbers across the four dose groups (measured in the "safety population") were: in the 2.5 mg group, 3 participants had non-serious events and 2 had serious events; in the 5 mg group, 13 had non-serious events and 7 had serious events; in the 7.5 mg group, 5 had non-serious events and 4 had serious events; and in the 10 mg group, 10 had non-serious events and 8 had serious events. The trial also tracked changes in a wide range of blood chemistry values — such as liver enzymes (ALT, AST, GGT), kidney markers, and proteins — from the start of the study to its end. The reported figures varied across dose groups and blood markers, with some values going up slightly and others going down slightly from the starting point. No single consistent direction was seen across all groups and all measures. It is worth noting that the number of participants in each group was quite small, and not all participants who started the trial completed it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02633293 · results posted 2 December 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02633293) enrolled 243 participants, all of whom received inhaled treprostinil, a medication delivered by inhalation. The trial was measuring changes in participants' ability to walk over six minutes (known as the six-minute walk test), along with two other measurements: a blood marker linked to heart strain called NT-proBNP, and a breathing test that measures how much air a person can forcefully breathe out (called forced vital capacity, or FVC). Seventy of the 243 participants completed the study, while 173 did not complete it; the data does not report the reasons. The reported data shows that, over the course of the study (measured at multiple points in time), the average change in how far participants could walk in six minutes ranged from an increase of about 12 metres at one point down to a decrease of about 11 metres at a later point. These figures represent how much the walking distance changed compared to where each participant started, and the reported numbers shifted in both directions across different time points. For the blood marker NT-proBNP, the reported data shows changes ranging from a decrease of around 5 units (pg/mL) to an increase of roughly 32 units across different time points — the data does not explain what drove those shifts. For the breathing test (FVC), the reported data shows small positive changes from baseline of 0.5, 2.0, and 3.0 percentage points at the time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01112306 · results posted 19 September 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 709 participants, all of whom received the study drug selexipag. Of those, 424 completed the study and 285 did not complete it. The trial was measuring how many participants experienced unwanted medical events (called adverse events) during treatment, as well as tracking how many participants were still alive at various points over time. The reported data shows that out of 709 participants who started, 684 experienced at least one adverse event that occurred during the treatment period. Of those, 420 participants experienced a "serious" adverse event — meaning one that was considered severe enough to involve hospitalisation, be life-threatening, or have another significant impact. Additionally, 129 participants stopped taking the study drug permanently because of an adverse event. It is important to note that an adverse event does not automatically mean the drug caused the event — it simply means the event happened while the person was in the study. The reported data also shows survival figures estimated at different points in time. At the start, 100% of participants were alive. Over time, this figure decreased: approximately 98.4%, then 96.3%, 94.0%, 92.0%, 85.3%, 79.3%, 75.2%, 71.2%, 66.8%, 63.3%, and finally 60.3% at the last reported time point. The specific time intervals these percentages correspond to were not clearly reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01560637 · results posted 2 June 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT01560637) enrolled 470 people who were already taking oral treprostinil (a medicine for pulmonary arterial hypertension — a condition involving high blood pressure in the lungs) as part of a previous study. All 470 participants were given the same treatment, called UT-15C (another form of oral treprostinil). Of the 470 who started, 272 completed the trial and 198 did not finish. The trial was primarily measuring the number of unwanted medical events (called adverse events) that occurred, and secondarily looking at changes in participants' physical ability, breathing difficulty, overall functioning, and a blood marker related to heart strain. The reported data shows that, across the 470 participants, a total of 450 adverse events of any kind were recorded. Of those, 362 events were considered possibly related to the study drug, 126 led to a participant stopping the drug, 206 were classified as serious (meaning they were medically significant), 182 were classified as severe, and 67 were both serious and possibly related to the study drug. Separately, 37 participants experienced a severe or serious event considered related to the study drug. For the secondary measures taken at 48 weeks (roughly one year), the reported data shows: participants walked an average of 20.1 metres more in a six-minute walk test compared to when they started; their self-reported breathlessness score (on a 0–10 scale, where lower is less breathlessness) changed by an average of −0.49 points; their overall functioning level (on a four-class scale, where lower is better) changed by an average of −0.2 points; and a blood marker linked to heart strain dropped by an average of 179.23 units (pg/mL). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02060487 · results posted 10 May 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 385 people in total — 129 in a group taking a 5 mg dose of sildenafil, 128 taking a 20 mg dose, and 128 taking an 80 mg dose. The trial was measuring overall survival (specifically, how many participants died during the study), how many participants experienced a significant worsening of their pulmonary arterial hypertension (a condition involving high blood pressure in the arteries of the lungs), and how far participants could walk in 6 minutes — a common way of measuring physical capacity in this condition. The reported data shows that, for the primary measure of deaths during the study, 34 deaths were recorded in the 5 mg group, 25 in the 20 mg group, and 19 in the 80 mg group. For clinical worsening events — which included deaths, hospital stays related to the condition, or measurable disease progression — the reported numbers were 52 participants in the 5 mg group, 36 in the 20 mg group, and 28 in the 80 mg group. Regarding the 6-minute walk test, the reported data shows the average change from the starting distance at 6 months was an increase of 12.2 metres in the 5 mg group, 27.3 metres in the 20 mg group, and 31.2 metres in the 80 mg group. At 12 months, the reported changes were increases of 14.3 metres, 35.7 metres, and 34.8 metres respectively. It is worth noting that the data shows zero participants were recorded as having "completed" the study across all three groups, though the reasons for this are not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02981082 · results posted 17 March 2022

  According to the results reported on ClinicalTrials.gov, this trial looked at a drug called Dimethyl Fumarate (DMF) compared to a placebo (a dummy treatment with no active ingredient) in people with a serious lung and heart condition. In total, just six people were enrolled — four in the DMF group and two in the placebo group. Of those, only one person in each group completed the full study, meaning three people in the DMF group and one in the placebo group did not finish. Because so few people took part and so few completed the trial, it is important to keep that context in mind when reading the numbers below. The main thing being measured was how far participants could walk in six minutes (known as the "6-minute walk distance"), with the reported figure showing the average percentage change from the start of the trial to 24 weeks. The reported data shows that the DMF group's average 6-minute walk distance changed by minus 7.07% (meaning, on average, they walked a shorter distance at 24 weeks than at the start), while the placebo group's average changed by minus 14.97% (a larger decline in distance walked). For the secondary outcomes — which included measures of breathing difficulty, time to health worsening, and certain markers measured in the blood — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00667823 · results posted 10 February 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 550 people, all of whom received macitentan 10 mg. Of those, 334 completed the study and 216 did not complete it. The trial was a single-group study — meaning there was no comparison group — and its primary focus was on tracking and counting unwanted medical events (called adverse events) and changes in certain blood test results that occurred during treatment and up to 28 days after stopping the study drug. The reported data shows that out of 550 participants, 527 experienced at least one treatment-emergent adverse event (that is, any unwanted medical occurrence that happened during or after treatment). Of those 550 participants, 354 experienced a serious adverse event — meaning an event considered medically significant, such as one requiring hospitalisation. The reported data also shows that 175 participants died during the study period, and 62 participants stopped taking the study drug permanently because of an adverse event. It is important to note that this trial enrolled people with a serious underlying illness, which is relevant context for understanding these numbers, though the trial results themselves do not separate out which events were related to the disease versus the study drug. Regarding blood test results, the reported data shows that various liver-related abnormalities were recorded in a number of participants — for example, 45 participants showed a moderate liver enzyme elevation and 8 showed a combination of elevated liver enzymes and elevated bilirubin (a marker of liver stress). For haemoglobin (a measure of red blood cells), 188 participants showed a meaningful drop from their starting level, and 33 participants had haemoglobin fall to a very low level (at or below 80 g/L). These figures reflect what was measured and counted; the trial was not designed to compare these numbers against a control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02279745 · results posted 22 December 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people with pulmonary arterial hypertension (a condition where blood pressure in the lungs is abnormally high) who were given an oral medicine called ralinepag. Of the 45 who started, 25 completed the trial and 20 did not finish. The trial was measuring several things related to how the heart and lungs were functioning, including the resistance blood faces when flowing through the lungs (called pulmonary vascular resistance), how much blood the heart pumps per minute (cardiac output and cardiac index), how far participants could walk in six minutes, and how long it took before their condition got measurably worse. The reported data shows that the average change in pulmonary vascular resistance from the start of the trial to the end was minus 52.2 units (dynes·sec/cm⁵), meaning the average measurement went down by that amount. The reported change in cardiac output was essentially zero (−0.0 litres per minute), and the reported change in cardiac index was also zero (0.0 litres per minute per square metre). For the six-minute walk test — where participants walk as far as they can in six minutes — the reported changes from baseline across multiple check-in points ranged from around 16 metres to 47 metres of additional distance. The reported data also shows that for the time until a first significant worsening event, the reported median (the middle value in the group) was 56.5 weeks. The reported data shows that for the functional class measure — a scale from I to IV describing how much a person's daily activity is limited by their condition — the numbers of participants in each category shifted somewhat across the different time points during the trial, though the detailed breakdown across all visits was not fully described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03270332 · results posted 30 August 2021

  According to the results reported on ClinicalTrials.gov, this trial involved 10 people in total, split into two groups of 5. It used a "crossover" design, meaning each person received both the active treatment (albuterol, a medicine sometimes used for breathing conditions) and a dummy treatment (placebo) at different points in the study. Nine of the 10 participants completed the trial; one person in the "Placebo first, then Albuterol" group did not finish. The trial was measuring how albuterol affected pressure and resistance in the blood vessels of the lungs, using ultrasound scans of the heart (echocardiograms). The reported data shows that the main thing being tracked was the change in mean pulmonary artery pressure — that is, the pressure inside the main blood vessel leading from the heart to the lungs, measured in units called mmHg (millimetres of mercury). The albuterol group showed a reported change of 6.5 mmHg, while the placebo group showed a reported change of 4.3 mmHg. For the secondary measure — resistance to blood flow through the lung vessels (pulmonary vascular resistance, measured in units called dyn.s.cm⁻⁵) — the reported change was 217 in the albuterol group and 108 in the placebo group. No further detail about the direction of these changes (whether pressure or resistance went up or down) was included in the submitted data. It is worth noting that with only around 10 participants, this was a very small study, and the reported data does not include information about whether the differences between groups were considered statistically meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03069716 · results posted 24 June 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03069716) looked at whether receiving daily smartphone text messages could encourage people with pulmonary hypertension (a condition affecting blood pressure in the lungs) to become more physically active. A total of 49 people entered an initial two-week lead-in period, of whom 42 continued and were then randomly placed into one of two groups: 20 people received smartphone text messages with a daily step-count goal, and 22 people did not receive text messages. Participants wore a Fitbit device to track their daily steps and activity over 12 weeks. The reported data shows that, over the 12-week period, the text-messaging group's average daily step count changed by +1,409 steps from where they started, while the no-text-message group's average daily step count changed by −149 steps (a small decrease). For the six-minute walk test — where participants walk as far as they can in six minutes — the text-messaging group's distance changed by +3 metres on average, while the no-text-message group's changed by −6 metres. The text-messaging group met their daily step goal on about 41% of days, compared with 24% for the no-text-message group. Daily aerobic activity minutes changed by +10 minutes in the text-messaging group and −16 minutes in the no-text-message group. A quality-of-life questionnaire (scored 0–50, where higher means worse) changed by −3 points in the text-messaging group and +1 point in the no-text-message group. A heart measurement called right ventricle strain changed by −0.1 percentage points in the text-messaging group and +0.4 percentage points in the no-text-message group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01392469 · results posted 21 June 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 21 participants, all of whom received a combination of three medicines: imatinib, bosentan, and sildenafil. Of those 21, 17 completed the trial and 4 did not. The trial was measuring how the presence of imatinib (at two different daily doses — 200 mg and 400 mg) changed the way the body absorbed and processed bosentan and sildenafil. Specifically, it tracked two things for each medicine: how much of the drug was present in the bloodstream over a dosing period (called "exposure"), and the peak level the drug reached in the blood. The reported data shows that when imatinib was added to the bosentan-and-sildenafil combination, the measured blood exposure to bosentan went from a reference value of 93.3 units up to 109 units with the lower imatinib dose and 131 units with the higher dose. For sildenafil, the reported exposure went from a reference of 7.22 units up to 9.82 units with the lower imatinib dose and 12.3 units with the higher dose. For the peak blood level of bosentan, the reported figures were 21.9 (reference), 21.8 (lower imatinib dose), and 23.4 (higher imatinib dose). For sildenafil's peak blood level, the figures were 2.44 (reference), 3.14 (lower dose), and 3.81 (higher dose). As a secondary measure, the number of participants who experienced at least one unwanted or unexpected symptom or medical event during each treatment period was reported as 10, 9, and 16 respectively across the three periods. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01027949 · results posted 10 May 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT01027949) enrolled 894 people, all of whom received a treatment called oral treprostinil. The trial was looking at whether continued use of this medicine over one year would affect participants' exercise capacity, measured using something called the 6-Minute Walk Test — a standard test where a person walks as far as they can in six minutes and the distance is recorded in metres. Of the 894 people who started the trial, 208 completed it, and 686 did not complete it (the reasons for this were not detailed in the reported data). The reported data shows that the main outcome being measured was the change in how far participants could walk in six minutes after 12 months, compared to where they started at the beginning of the trial. According to the results reported on ClinicalTrials.gov, the average change in walking distance was 22.0 metres. This means that, on average, participants walked 22.0 metres further in the six-minute test after 12 months than they did at the start. No other outcome measures were included in the submitted results data, so no further figures can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01051960 · results posted 2 November 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people, all of whom received a medication called ambrisentan. Eleven participants completed the study, while one did not finish. The trial was designed to look at what happens to blood pressure in the lungs during exercise in people with systemic sclerosis (a condition also known as scleroderma), and to track changes over 24 weeks across a range of measurements including exercise capacity and quality of life. The reported data shows that the primary measurement — blood pressure in the lung vessels during exercise — was reported as 37.4 mmHg (millimetres of mercury, a standard unit for measuring pressure) at the end of the study period. For the secondary measurements, participants walked an average of 44.5 metres more in a six-minute walking test compared to the start of the study. On a quality-of-life measure called the HAQ-DI — a questionnaire scoring daily activity difficulty from 0 (no difficulty) to 3 (completely unable) — the reported score was 1.12. On the St. George's Respiratory Questionnaire, which measures how lung disease affects daily life on a scale from 0 to 100 (where lower means better health status), the reported score was 13.2. The reported data also shows that zero participants exceeded what researchers defined as a meaningful threshold for improvement on either the SF-36 or HAQ-DI quality-of-life scales. It is worth noting that the reported data does not include a comparison or "before" figure for most of these measurements, so it is not possible from the available data alone to describe the full picture of change over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00910429 · results posted 22 October 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT00910429) was an extension study involving two groups of participants who had previously taken part in an earlier trial of riociguat, a medicine being studied for a serious lung condition. One group (155 people) had been taking riociguat in the earlier trial and continued on it here, while the second group (82 people) had previously been on a placebo (a dummy treatment) and then switched to riociguat. In total, 237 people started the study; 116 in the first group and 61 in the second group completed it. The trial was primarily tracking unwanted medical events that occurred during treatment, as well as deaths, to understand what happened to participants over time. The reported data shows that, among those who experienced any treatment-emergent adverse event (that is, any unwanted health event that arose during the study period), 153 out of 155 participants in the continuing-riociguat group and 82 out of 82 in the former-placebo group had at least one such event recorded. Events considered possibly related to the study medicine were reported in 77 people in the first group and 44 in the second. Serious adverse events were recorded for 96 people in the first group and 56 in the second. Deaths during the study were reported for 22 people in the continuing-riociguat group and 13 in the former-placebo group. The reported data also shows results from blood tests taken during the study. Shifts in blood measurement levels — where a reading moved from a normal or low starting point to an abnormally high level, or from normal or high to an abnormally low level — were recorded across both groups for a range of standard blood markers. For example, changes in haemoglobin (a protein in red blood cells that carries oxygen) from the start of the study showed an average increase of about 1.04 g/dL in the continuing-riociguat group, while the former-placebo group showed an average decrease of about 1.37 g/dL; the data does not include a full explanation for this difference. Several other blood chemistry and coagulation (blood-clotting) markers were also tracked, with various small percentages of participants in each group showing shifts in either direction, as reported in the trial records. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00863681 · results posted 22 October 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT00863681) enrolled a total of 396 participants across three groups. All participants received riociguat during this extension study — one group had previously taken riociguat at a dose range of 1.0–2.5 mg (231 people), a second group had previously been on placebo (109 people), and a third had previously taken riociguat at a lower dose range of 1.0–1.5 mg (56 people). The trial was primarily measuring how many participants experienced adverse events (unwanted medical occurrences) during treatment, and how many participants died during the study period. The reported data shows that, when it came to adverse events that occurred during treatment, the numbers were high across all three groups — 229 out of 231 participants in the first group, 108 out of 109 in the second group, and all 56 in the third group experienced at least one such event. Deaths during the study period were reported as 48 in the first group, 30 in the second group, and 7 in the third group. The trial also tracked changes in blood and chemistry test results during treatment. The reported data shows that abnormal shifts in these test values — both higher and lower than normal — were recorded across all three groups at varying percentages, with some individual measures showing shifts in a notable proportion of participants. The specific percentages for each test varied but were reported across multiple categories of blood and chemistry markers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04339296 · results posted 20 October 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT04339296) enrolled 50 people in total — 24 in the intervention group (who used an automated medication dispensing platform called AdhereNet) and 26 in a control group (who tracked their medications manually using paper calendars). The trial was measuring how well people stuck to their medication schedules, looking at this in two ways: through recorded data from the device or calendars, and through participants' own ratings of how well they felt they were taking their medications. The reported data shows that, for recorded medication adherence, the intervention group had an average score of 98.35% of medications taken at the prescribed time, while the control group recorded an average of 91.17%. For self-reported adherence — where participants rated themselves on a scale of 1 (not adhering) to 10 (fully adhering) — the reported data shows scores appear to have been collected at two time points. The intervention group's self-reported scores went from 7.63 to 9.13, while the control group's scores went from 7.20 to 8.27. It is worth noting that not all participants who started the trial completed it: 16 people finished in the intervention group and 17 in the control group, meaning some data may not be reflected in the final figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00989963 · results posted 30 September 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT00989963) enrolled 36 participants across three groups, all of whom had pulmonary arterial hypertension (a condition where the blood pressure in the lungs is abnormally high). The three groups received different doses of the study treatment: a low fixed dose (60 micrograms), a high fixed dose (240 micrograms), or a "maximum tolerated dose" (the highest dose each individual could handle). The trial was primarily measuring changes in three heart-and-lung measurements after 12 weeks: pulmonary vascular resistance (how hard it is for blood to flow through the lung's blood vessels), cardiac output (how much blood the heart pumps per minute), and mean pulmonary arterial pressure (the average pressure inside the lung's arteries). Of the 36 who started, 33 completed the trial — one person in each group did not finish. The reported data shows the following changes from the starting point to Week 12. For pulmonary vascular resistance, the low-dose group changed by +0.37 Wood Units, the high-dose group by 0.00, and the maximum tolerated dose group by +0.13 — meaning the values were largely similar to where they started. For cardiac output, the changes were +0.16, +0.07, and +0.35 litres per minute respectively. For pulmonary arterial pressure, the low-dose group changed by +0.42 mmHg, the high-dose group by −1.45 mmHg, and the maximum tolerated dose group by +4.10 mmHg. On the secondary measure of how far participants could walk in six minutes, the reported data shows changes that varied across the groups and time points (Week 6 and Week 12), ranging from small increases of around 2 metres up to roughly 53 metres, though the trial notes that no formal statistical analysis was performed on these figures. For the laboratory measure, the reported data shows that 5 participants in the low-dose group, 3 in the high-dose group, and 3 in the maximum tolerated dose group had at least one noteworthy laboratory result after starting treatment, as judged by the investigators. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00777920 · results posted 30 September 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 140 people, all of whom received a medicine called ambrisentan. The study was an open-label, long-term trial — meaning everyone received the same treatment and the researchers knew what participants were taking. Of the 140 people who started, 90 completed the study and 50 did not finish. The main thing the trial was set up to measure was how many participants experienced adverse events (that is, unwanted or unexpected medical occurrences) over the course of long-term use of ambrisentan. The reported data shows that 90.7% of participants experienced at least one adverse event during the study period. No further breakdown of those adverse events — such as how serious they were, what types occurred, or how often — was included in the structured results submitted to ClinicalTrials.gov. It is also worth noting that no secondary outcome measure data appears to have been reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02310672 · results posted 24 September 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 87 adults who received macitentan 10 mg, a medicine being studied for pulmonary arterial hypertension (a condition where blood pressure in the arteries between the heart and lungs is abnormally high). Of the 87 who started, 72 completed the study and 15 did not finish. The trial ran for 26 weeks and was measuring changes in how the right side of the heart was pumping, using two main methods: a specialised heart scan called cardiac MRI, and a procedure called right heart catheterisation, which directly measures the resistance the right side of the heart has to work against when pumping blood through the lungs. The reported data shows that for the two primary (main) measurements, participants showed an average increase of about 15.2 millilitres in right ventricular stroke volume — that is, the amount of blood pumped out by the right side of the heart with each beat — as measured by MRI. The resistance against which the right side of the heart was pumping (called pulmonary vascular resistance) was reported as a ratio of 0.63 compared to the starting point, meaning the recorded value at week 26 was about 63% of what it was at the beginning of the study. For the secondary (additional) measurements, the reported data shows changes in several other heart measurements taken by MRI: the volume of the right heart chamber at its most relaxed point changed by an average of minus 6.22 millilitres, the volume at its most contracted point changed by minus 16.39 millilitres, the proportion of blood pumped out with each beat (ejection fraction) increased by an average of 10.14 percentage points, and the mass (weight) of the right heart muscle changed by minus 10.10 grams. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02558231 · results posted 11 September 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02558231) enrolled 247 people with pulmonary arterial hypertension (a condition where blood pressure in the lung arteries is abnormally high). Participants were divided into two groups: 123 people received three medicines together (macitentan, tadalafil, and selexipag), while 124 received two medicines plus a dummy pill (macitentan, tadalafil, and a placebo). The trial ran for 26 weeks and was primarily measuring changes in pulmonary vascular resistance — that is, how much resistance the heart faces when pumping blood through the lung arteries, measured by a procedure called a right heart catheterisation. By the end of the study, 98 participants in each group had completed the trial. The reported data shows that for the main measurement — resistance in the lung arteries — both groups recorded a ratio of less than 1 compared to their starting point, meaning resistance was lower at week 26 than at the beginning. The triple-medicine group recorded a ratio of 0.46 and the double-medicine group recorded 0.48 (where a lower number means a greater reduction from the starting level). For the secondary measurements, the reported data shows that both groups also walked further in a standard six-minute walk test compared to their starting point (an increase of roughly 55 metres in the triple group and 56 metres in the double group). A blood marker linked to heart strain (NT-proBNP) showed a ratio of 0.26 in the triple group and 0.25 in the double group — again, below 1, meaning levels were lower than at the start. Blood pressure in the lung arteries dropped by about 13 mmHg in the triple group and 12 mmHg in the double group, and pressure in the right atrium of the heart dropped by roughly 1.8 mmHg and 1.7 mmHg respectively. Around 99% of the triple-medicine group and 98% of the double-medicine group showed no worsening of their disease class over the 26 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02279160 · results posted 14 July 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02279160) looked at a drug called APD811 in people with pulmonary arterial hypertension (PAH) — a condition affecting blood pressure in the lungs. A total of 61 people took part: 40 received APD811 and 21 received a placebo (a dummy treatment with no active ingredient). Of those, 34 in the APD811 group and 19 in the placebo group completed the study. The trial measured two main things: the resistance to blood flow through the lungs (called pulmonary vascular resistance, or PVR — essentially how hard the heart has to work to push blood through the lung vessels), and how far participants could walk in six minutes (a standard test of physical capacity in this condition). The reported data shows that, when looking at the change in lung blood-flow resistance from the start of the study to around Week 22, the APD811 group had a baseline PVR value of 514.6 units (dyn·sec/cm⁵) and the placebo group had a baseline value of 512.0 units. For the six-minute walk test, the reported baseline distance was 36.2 metres in the APD811 group and 29.4 metres in the placebo group. It is important to note that the data as submitted reports these as baseline figures; the actual change-from-baseline results for each outcome were not separately reported in the structured data available, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02507011 · results posted 16 June 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02507011) involved a very small number of participants — just 2 people in total. It used a "crossover" design, meaning each person took both carvedilol (a type of heart medication) and a placebo (a dummy pill with no active ingredient) at different times. The trial was measuring changes in how well the right side of the heart pumps blood, using a heart scan called a cardiac MRI. The specific measurement used is called "right ventricular ejection fraction" — this is simply a percentage that reflects how much blood the right side of the heart pushes out with each beat. The reported data shows that, on average, participants' right ventricular ejection fraction changed by 10 percentage points while taking carvedilol, compared to 2.5 percentage points while taking the placebo. No other outcome measures were included in the submitted results data beyond this single primary measure. Secondary outcome data was not reported in the submitted results. It is important to note that only 2 people took part in this trial, which is an extremely small number. This means the reported figures are very limited in what they can tell us, and no broad conclusions can be drawn from results of this size alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02939599 · results posted 28 February 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02939599) enrolled five people in total — three in Arm 1 and two in Arm 2 — who had a condition called pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of the lungs. The trial was set up to track unwanted health events (called adverse events) over a two-year period, and also to measure how a drug called QCC374 moved through participants' bodies after they took it (known as pharmacokinetics, or PK — basically, how the drug is absorbed and how long it stays in the bloodstream). It is worth noting that none of the five participants were recorded as having completed the study. The reported data shows that, for the primary outcome — tracking unwanted health events — two out of three participants in Arm 1 and two out of two participants in Arm 2 experienced some kind of adverse event. One participant in Arm 1 experienced a serious adverse event; none were reported in Arm 2. For the drug-level measurements in the QCC374 group, the reported data shows the peak amount of drug detected in the blood ranged from 82 to 664 pg/mL (picograms per millilitre, a very small unit of measurement), and the time it took to reach that peak was between roughly 2 minutes and 15 minutes. Measures of how much drug was present in the blood over time also varied across the two reported values (118 to 526, and 134 to 566, in their respective units). For the six-minute walk test — where participants walk as far as they can in six minutes — a single value of 452 metres was reported as the change from the starting point, though no further breakdown of this figure was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01560624 · results posted 13 February 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT01560624) enrolled 690 people with pulmonary arterial hypertension (a condition where the blood pressure in the arteries supplying the lungs is abnormally high). Participants were randomly assigned to receive either a medicine called UT-15C (346 people) or a placebo — a dummy treatment with no active ingredient (344 people). The trial was mainly measuring how long it took before a participant experienced a "clinical worsening event," which was defined as death from any cause, a hospital stay due to worsening of their condition, needing to start a new type of inhaled or infused medication, or other signs that their condition was getting worse. The reported data shows that, on average, participants in the UT-15C group reached a clinical worsening event after approximately 60.6 weeks, compared to approximately 49.3 weeks in the placebo group. In total, 91 people in the UT-15C group and 133 people in the placebo group experienced a clinical worsening event during the study. For the secondary measurements, the reported data shows that both groups could walk similar distances at the start of the study (around 393–399 metres in a 6-minute walk test), and at week 24 the UT-15C group averaged about 395 metres while the placebo group averaged about 372 metres. A blood marker linked to heart strain (NT-proBNP) was also measured — the UT-15C group's level sat at roughly 0.79 times their starting level at week 24, while the placebo group's level sat at roughly 1.12 times their starting level, meaning the placebo group's marker had risen above where it began. For a measure of physical functioning (WHO Functional Class, a 4-level scale of how limited daily activities are), at week 48 the reported data shows 46 UT-15C participants improved, 203 stayed the same, and 66 worsened, compared with 38 improved, 170 stayed the same, and 103 worsened in the placebo group. It is important to note that these figures are simply the numbers as recorded and submitted by the trial's sponsor, and do not on their own tell us whether any difference between groups was meaningful or due to chance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00792571 · results posted 26 December 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 18 participants, all of whom received a drug called Beraprost Sodium. The trial was an extension study looking at participants who had a condition called pulmonary arterial hypertension (PAH — a form of high blood pressure in the arteries supplying the lungs). Of the 18 who started, 8 completed the study and 10 did not finish. The study was primarily tracking any unwanted health events (called adverse events) that arose during treatment, as well as some measures of physical function. The reported data shows that all 18 participants experienced at least one treatment-emergent adverse event (that is, an unwanted health event that appeared or got worse after starting the drug), and a total of 156 such events were recorded across the group. On a secondary measure, participants walked an average of about 10.55 metres more in a six-minute walk test by the end of the study compared to when they started. Breathlessness scores (rated on a 0–10 scale, where lower is better) changed by an average of −0.09, meaning there was very little difference from the starting point. One participant experienced a clinical worsening event defined as death, transplant, or surgical procedure, while 6 experienced worsening defined as hospitalisation or starting a new PAH treatment. For the WHO Functional Class measure (a way doctors grade how much a condition limits daily activity), the reported data shows 1 participant's condition deteriorated, 7 remained the same, 4 improved, and 6 had data that was not reported or categorised differently — the breakdown across all categories was not fully detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02111980 · results posted 24 December 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 50 participants, all of whom completed the study with no drop-outs. All participants had an implanted heart device — either a permanent pacemaker (PPM) or an implantable cardiac defibrillator (ICD) — and were scanned using a product called RF Assure. The trial was measuring whether being scanned with this product caused any changes to several settings on participants' heart devices, including the pacing mode (how the device coordinates heartbeat signals), pacing polarity (the electrical pathway used), base rate (the minimum beats per minute the device is set to deliver), maximum tracking rate (the fastest rate at which the device will follow the heart's own signals), a timing interval called AV delay (the pause between the upper and lower heart chambers being triggered), and battery voltage. The reported data shows that, for pacing mode, the number of participants in each device mode category was identical before and after the scan — for example, 29 participants were in one mode both before and after, 8 in another, 2 in another, and 1 in another. Similarly, the reported pacing polarity counts were unchanged between pre- and post-scan checks (40, 5, and 3 participants in each polarity category, respectively, at both time points). The reported median base rate was 60 beats per minute both before and after scanning, and the median maximum tracking rate was 130 beats per minute at both time points. The reported AV delay figures were also the same before and after (230 milliseconds and 250 milliseconds for the two measurements taken). Battery voltage was reported as 2.745 millivolts before scanning and 2.744 millivolts after scanning. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01332331 · results posted 8 October 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01332331) enrolled 41 people across two groups — 21 received a lower dose of a medicine called ambrisentan and 20 received a higher dose. The trial was primarily measuring safety-related observations: it tracked unwanted medical events (called adverse events) and serious adverse events, as well as results from blood tests and physical examinations, to see how many participants had readings that fell outside a predefined normal range. The reported data shows that when it came to general adverse events (any unwanted medical occurrence during the study), 16 out of 21 participants in the low-dose group and 16 out of 20 in the high-dose group had at least one such event recorded. For serious adverse events — those involving hospitalisation, life-threatening situations, or similar significant outcomes — 6 participants in the low-dose group and 2 in the high-dose group were reported. For the blood test measurements (liver enzymes ALT, AST, GGT, total bilirubin, and kidney marker creatinine), the reported data shows no participants in either group reached the flagged threshold levels, with one exception: one person in the low-dose group had a total bilirubin reading flagged. For blood-related measures (haemoglobin, haematocrit, and platelet count), small numbers of participants — mostly one or two per group — were reported as having readings outside the predefined ranges. Physical examination of liver size also showed small numbers of participants, one or two across both groups at various time points, recorded as having an abnormal finding. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02927366 · results posted 7 August 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02927366) enrolled 8 participants in total — 6 received the investigational treatment QCC374 and 2 received a placebo (a dummy treatment with no active ingredient). The trial was looking at whether 16 weeks of QCC374 had any effect on several heart and lung measurements in people with Pulmonary Arterial Hypertension (PAH), a condition where the blood pressure in the arteries supplying the lungs is abnormally high. The main measurement the trial focused on was something called Pulmonary Vascular Resistance (PVR) — essentially a measure of how hard the heart has to work to push blood through the lungs. Because the trial was very small, the researchers only performed a descriptive analysis, meaning they simply described the numbers rather than running formal statistical tests to compare the groups. The reported data shows that for the primary measure (PVR), the numbers submitted to ClinicalTrials.gov appear incomplete or presented as ratios rather than straightforward change scores, with values of approximately 1.07 reported for the QCC374 group and 1.05 for the placebo group at week 16 — the full breakdown of what these figures represent was not clearly detailed in the submitted data. For the six-minute walk test (how far someone can walk in six minutes), the QCC374 group started at an average of around 444 metres, while the placebo group started at around 459 metres; over time, the reported data shows the QCC374 group's distances changed by figures ranging from around −12 to +13 metres across different time points, while the placebo group's distances changed by roughly +10 to +14 metres. For heart output (how much blood the heart pumps per minute), the QCC374 group was reported at around 4.33 litres per minute at baseline and the placebo group at around 3.61 litres per minute, with both groups showing modest variation across time points. Several other measurements — including cardiac index, wedge pressure, and resistance in the body's wider blood vessels — were also reported, though some data points for those measures were not fully submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01416636 · results posted 10 June 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 105 people with a severe form of a lung blood pressure condition called chronic thromboembolic pulmonary hypertension — a type that could not be treated with surgery. Participants were split into two groups: 53 received a higher dose of a medication called treprostinil sodium (delivered under the skin), and 52 received a much lower dose. The trial ran for 24 weeks. The main thing being measured was how far participants could walk in six minutes, which is a standard way of gauging physical capacity in this type of condition. The reported data shows that, on average, people in the high-dose group walked about 45 metres further after 24 weeks compared to where they started, while people in the low-dose group walked about 4 metres further on average. For a secondary measure looking at "clinical worsening" — defined as a notable drop in walking distance, a decline in heart function class, hospitalisation needing extra treatment, or death — 7 participants in the high-dose group and 12 in the low-dose group experienced this at some point during the trial. On a breathlessness rating scale used during the walk test (where a lower score means less breathlessness), the high-dose group's score changed by −0.44 and the low-dose group's by −0.13. A quality-of-life questionnaire showed score changes of −6.36 (high dose) and −4.63 (low dose), where a lower score indicates fewer reported limitations. A blood marker related to heart strain showed a reported change of +0.84% in the high-dose group and +41.68% in the low-dose group from their starting levels. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00840463 · results posted 22 May 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT00840463) enrolled a very small number of participants — 3 people received ambrisentan and 1 person received a placebo (an inactive treatment used for comparison). The trial was looking at a lung condition involving high blood pressure in the lungs, and it measured changes in how well blood flows through the lungs, how far participants could walk in six minutes, their physical function scores from a questionnaire, and whether any clinically significant unwanted medical events occurred. The reported data shows that for the main measure — resistance to blood flow in the lungs (measured in "Wood units," a standard unit for this type of measurement) — the ambrisentan group showed an average change of −0.75 (a decrease), while the placebo group showed an average change of +2.81 (an increase). For the six-minute walk test, the ambrisentan group's distance changed by −22 metres on average, while the placebo group's changed by +53 metres. On the physical functioning questionnaire (scored 0–100, where higher means less difficulty), the ambrisentan group's score changed by +12.5 points and the placebo group's score showed no change (0). Regarding unwanted medical events, the reported data shows 2 participants in the ambrisentan group were free from clinically significant adverse events and 1 experienced one, while the 1 placebo participant was free from such events. No change in functional class (a measure of how symptoms affect daily activity) was reported for any participant in either group. It is important to note that with only 4 participants in total, this was an extremely small trial, and the numbers reported here represent only those few individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02234141 · results posted 10 April 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02234141) looked at a drug called selonsertib in people with pulmonary arterial hypertension — a condition where blood pressure in the arteries leading to the lungs is abnormally high. A total of 151 participants took part in the initial 24-week treatment period, split across three selonsertib dose groups (2 mg: 39 people; 6 mg: 38 people; 18 mg: 37 people) and a placebo group (37 people). The trial's main goal was to measure any change in "pulmonary vascular resistance" (PVR) — a way of describing how much the lung's blood vessels resist the flow of blood from the heart — after 24 weeks, using a procedure called a right heart catheterisation. The reported data shows that for the primary outcome (change in PVR from the start of the trial to week 24, measured in units called dyne·sec/cm²), the selonsertib 6 mg group showed a reported average change of −28, and the 18 mg group showed −21, meaning their PVR readings were lower at week 24 than at the start. The 2 mg selonsertib group showed a change of +35 (higher than at the start), and the placebo group showed a change of +6. For the secondary outcomes measured at week 24 — including the amount of blood the heart pumps per minute (cardiac index), blood pressure in the pulmonary artery (mPAP), blood pressure in the right atrium of the heart (mRAP), oxygen levels in returning blood (SVO2), and right ventricular cardiac power — the reported changes across all groups were generally small, with figures close to zero in most cases, as detailed in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02885012 · results posted 8 April 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02885012) enrolled a total of three participants — one person who switched to Letairis (ambrisentan) from a medicine called Bosentan, and two people who switched to Letairis from a medicine called Macitentan. All three participants completed the study. The trial was measuring how switching to Letairis affected the heart's pumping function, quality of life, and a blood marker linked to heart strain in people with pulmonary hypertension (high blood pressure in the lungs). The reported data shows the following numbers for the main outcome — change in the amount of blood the heart pumps with each beat (called stroke volume, measured in millilitres per beat): the participant who switched from Bosentan showed a change of −2.8 ml/beat, while the two participants who switched from Macitentan showed a change of +8.7 ml/beat. For the quality-of-life questionnaire (scored 0–50, where higher scores mean worse quality of life), the reported changes were +3 points for the Bosentan-switch group and +4 points for the Macitentan-switch group. For the blood marker (NT-proBNP, a substance released when the heart is under pressure — higher levels suggest worse disease), the reported change was +926 pg/mL in the Bosentan-switch group and −78 pg/mL in the Macitentan-switch group. It is important to note that with only three participants in total, these numbers describe a very small group of people and should be interpreted with considerable caution. The trial was extremely small, and no broader conclusions can be drawn from figures based on so few individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02304705 · results posted 13 March 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02304705) enrolled 33 people in total — 16 in the placebo group and 17 in the sildenafil group. The trial was measuring whether sildenafil, compared to a placebo (an inactive treatment), had any effect on how far participants could walk in six minutes on a treadmill. Participants were tested at the start of the trial and again after 90 days of treatment. Not everyone finished the study — 4 people in the placebo group and 7 in the sildenafil group did not complete it. The reported data shows that, on average, participants in the placebo group increased the distance they walked in six minutes by 228 feet (roughly 70 metres) between the start and end of the study. Participants in the sildenafil group increased their distance by 135 feet (roughly 41 metres) over the same period. These numbers represent the average change in walking distance — not the total distance walked. The trial also planned to measure other things, including heart function, blood pressure, and how well blood flows through the lungs, but the results for those additional measurements were not reported in the data submitted to ClinicalTrials.gov. It is worth noting that the number of people in this trial was quite small, which is worth keeping in mind when considering what these figures mean. The reported data shows only what was measured and recorded — it does not indicate why the numbers came out the way they did, and no conclusions about the reasons behind the differences should be drawn from these figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02885636 · results posted 5 February 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total — 15 who inhaled albuterol (a medicine commonly used for breathing conditions) and 15 who inhaled a saline (salt water) placebo. All 30 participants completed the study. The trial was looking at how blood pressure and blood flow through the lungs — measured in units called "wood units" — changed during rest and during light exercise (pedalling at 20 watts on a stationary bike), before and after receiving the study treatment. A lower wood unit number after treatment would suggest the lungs' blood vessels were under less resistance. The reported data shows the following for the main (primary) measure — the change in lung blood vessel resistance during exercise: the albuterol group showed a change of −0.6 wood units (a decrease), while the placebo group showed a change of +0.1 wood units (a slight increase). For the secondary measures, the reported data shows: resting lung blood vessel resistance changed by −0.6 wood units in the albuterol group and −0.3 in the placebo group. A pressure reading inside the lungs taken during exercise (called pulmonary capillary wedge pressure, which reflects how hard the heart is working to push blood through) changed by −2 mmHg in the albuterol group and −3 mmHg in the placebo group; at rest, both groups showed a change of −2 mmHg. A measure of how flexible or "springy" the lung arteries were during exercise changed by +1.6 units in the albuterol group versus 0.0 in the placebo group; at rest, the changes were +1.2 and +0.7 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01917136 · results posted 5 February 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 21 participants, all of whom completed the study with no drop-outs. The trial was looking at changes in the function of the right ventricle — the right-side pumping chamber of the heart — in people who underwent a combination of two types of specialised heart scans (called 11C-acetate and 18F-FDG PET scans) alongside cardiac MRI (a detailed imaging scan of the heart). The reported data shows that the primary outcome — a measure of how right ventricle function changed — was recorded as 7.56 percent. This figure represents the change in right ventricle function as measured by cardiac MRI across the study group. No further breakdown of this result (such as individual variation or comparisons between sub-groups) was included in the data reported to ClinicalTrials.gov. Secondary outcome data was not reported in the structured results available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01484431 · results posted 5 February 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 19 children with pulmonary arterial hypertension (a condition involving high blood pressure in the lungs) across three weight groups: 6 children under 25 kg (lighter), 7 children between 25 and 40 kg (middle), and 6 children 40 kg or more (heavier). The trial was mainly measuring how the body processed a medicine called tadalafil — specifically, how much of the medicine built up in the blood over time at a stable, ongoing dose. Children received different dose amounts depending on their weight group, across multiple study periods. The reported data shows that for children in the lighter and middle weight groups given a 20 mg dose, the total amount of tadalafil measured in the blood over a dosing period (a measure called AUC, which reflects overall drug exposure) was reported as 8,170 and 8,390 ng·hr/mL respectively, with lower bounds of the prediction range at 4,550 and 5,000. For the heavier weight group given a 40 mg dose, the reported figure was 15,200 ng·hr/mL, with a lower bound of 8,990. Average blood concentration figures followed a similar pattern across the weight groups. For the secondary outcomes, the reported data shows that 50% of children in the lighter group, 28.57% in the middle group, and 33.33% in the heavier group experienced what the trial defined as "clinical worsening" (a combined measure including events such as hospitalisation or needing new treatments). Taste acceptability data was only reported for the lighter weight group and was not reported for the other two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01409031 · results posted 1 February 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01409031) was set up to compare intravenous sildenafil against a placebo (an inactive substance) in a very small number of participants. Only three people were enrolled in total — one in the intravenous sildenafil group and two in the placebo group. The trial was measuring things like improvements in the body's oxygen levels, whether participants needed additional breathing treatments such as inhaled nitric oxide or a heart-lung bypass procedure called ECMO, changes in blood pressure in the lungs, how long participants needed extra oxygen or a breathing machine, and the age at which they left hospital. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — neither the primary outcomes (oxygen improvement and need for additional treatments) nor any of the secondary outcomes (lung blood pressure changes, time on extra oxygen, time on a breathing machine, or age at discharge). This means the actual measurements for these outcomes are not available in the publicly reported data. The reported data also shows that one participant in the sildenafil group did not complete the study, while both participants in the placebo group did complete it. Because the trial enrolled only three participants and no outcome numbers were reported, there is very little information available from this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02276872 · results posted 4 January 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02276872) enrolled 32 people with pulmonary arterial hypertension (PAH — a condition involving high blood pressure in the arteries of the lungs) across three groups. Ten participants were switching from an injected/intravenous form of the medication treprostinil to an oral (tablet) form; ten were switching from an inhaled prostacyclin medicine to the oral form; and twelve were adding the oral tablet to their existing PAH treatment for the first time. The trial was measuring whether participants could successfully make these transitions and stay on the oral tablet over 24 weeks. The reported data shows that, for the primary outcome, 9 out of 10 participants in the "switching from injected" group, 10 out of 10 in the "switching from inhaled" group, and 12 out of 12 in the "add-on" group met the definition of a successful transition or initiation by Week 24. For the secondary outcomes, exercise-related measurements (how much oxygen the body used at peak effort, and how hard the heart and lungs were working during exercise) showed mixed changes across the three groups — some groups showed small increases and others small decreases from their starting values, but the reported data does not include the full detail needed to characterise these further. In terms of PAH symptoms, the reported data shows that the majority of participants in each group had no change in their symptom scores over the 24 weeks. For functional class (a measure of how much a condition limits daily activity), most participants — 9, 7, and 9 across the three groups respectively — showed no change, while small numbers showed either an improvement or a worsening. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01934647 · results posted 22 October 2018

  According to the results reported on ClinicalTrials.gov, this trial looked at a drug called MK-8892 in three different dose groups — 1 mg, 4 mg, and 8 mg. A total of seven people took part: two in the 1 mg group, two in the 4 mg group, and three in the 8 mg group. All seven participants completed the study. The trial was measuring how much the drug changed a measure called pulmonary vascular resistance (PVR) — which is essentially the amount of resistance to blood flow through the lungs — as recorded during a procedure that monitors blood pressure inside the heart and lungs. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for the primary outcome measure — that is, the peak percentage change in pulmonary vascular resistance from the starting point. The data field for this measurement was left empty, so no figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02734953 · results posted 24 September 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 10 participants, all of whom completed the study (there were no dropouts). The trial was investigating the effects of inhaled nitric oxide (iNO) — a gas delivered by breathing — on people with pulmonary hypertension (high blood pressure in the blood vessels of the lungs). Researchers used a small implanted sensor called a CardioMems device to measure pressure inside the pulmonary artery (the main blood vessel carrying blood from the heart to the lungs), and also asked participants to do a standard walking test before and approximately two hours after receiving the treatment. The reported data shows the following changes between the pre-treatment and post-treatment measurements. Pulmonary artery pressures (the main outcome being measured) changed by an average of −4.86 mmHg for the peak (systolic) pressure, −2.40 mmHg for the lowest (diastolic) pressure, and −3.45 mmHg for the average (mean) pressure — where a negative number means the pressure was lower after the intervention. For the secondary outcomes, the reported data shows an average increase in the heart's output of blood of 0.76 litres per minute, and participants walked an average of 12.6 metres further in the six-minute walking test after the intervention. Oxygen levels in the blood changed by an average of −1 percentage point (slightly lower after the intervention). Participants' self-reported breathing difficulty on a 0–10 scale changed by an average of −0.4 points (slightly lower after the intervention). The number of participants who needed to change their oxygen flow through a nasal tube was reported as zero. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01272388 · results posted 12 September 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT01272388) enrolled a very small number of participants — just one person in the Tadalafil group and no one in the Placebo group. The trial was measuring quality of life using a heart-related questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ), where scores range from 0 to 100 with higher scores indicating better quality of life, as well as how far participants could walk in six minutes. The reported data shows that the single participant in the Tadalafil group scored 87 on the KCCQ questionnaire at one time point and 81.25 at another. For the six-minute walk test, the reported data shows distances of 1,080 feet and 860 feet recorded for that same participant. No results were reported for a Placebo group, as no participants were enrolled in that group. It is important to note that because only one person participated in this trial, the reported numbers reflect the experience of a single individual and cannot be used to draw any broader conclusions. No placebo comparison data was reported at all. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01321073 · results posted 4 May 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT01321073) enrolled 64 participants, all in a single group receiving the same treatment — there was no comparison group. The trial was looking at a specific type of catheter (an implanted line used to deliver medication) in people with pulmonary arterial hypertension, a condition affecting blood pressure in the lungs. Of the 64 people who started, 57 completed the study and 7 did not. The main thing the trial was measuring was how often serious catheter-related complications occurred — meaning problems with the implanted line that required some kind of invasive procedure to deal with. Pneumothorax (a collapsed lung, which can sometimes happen when a line is inserted) was also counted as part of this measure. The reported data shows a rate of 0.27 complications per 1,000 patient-days. To put that in everyday terms, "patient-days" is simply the total number of days all participants were monitored added together — so this figure reflects how frequently these complications were recorded across all that combined time. No secondary outcome measures were included in the data submitted to ClinicalTrials.gov for this trial, so those results cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01060020 · results posted 25 April 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 20 adults, all of whom completed the study — none dropped out. Every participant received sildenafil (either a 40 mg or 80 mg dose). The trial was measuring how sildenafil affected blood pressure in the lungs and the overall function of the heart and blood vessels, using a range of measurements taken before and after the medication was given. The reported data shows that, on average, the pressure in the main artery supplying the lungs (called the pulmonary artery) fell by 25% after the dose was given. A related measure — how hard it is for the heart to push blood through the lung's blood vessels (called pulmonary vascular resistance) — was reported to have fallen by 29%. The amount of blood the heart pumped out relative to body size (cardiac index) showed a reported change of plus 4%, meaning it was slightly higher after the dose. Two further measurements were also reported: one relating to how the heart fills with blood between beats (the "load independent index of diastolic filling"), which showed values of 1.02 before and 1.03 after the dose; and a measure of how the heart muscle squeezes (global longitudinal strain), recorded as −13.5% at the start and −13.8% at 60 minutes after the dose. The small differences in these last two measures were noted in the data, but no further interpretation was provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02021292 · results posted 23 January 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02021292) enrolled 80 people in total — 40 received macitentan and 40 received a placebo (a dummy treatment with no active ingredient). All 40 people in the macitentan group completed the study, while 37 of the 40 in the placebo group completed it. The trial was looking at a measure of blood flow resistance in the lungs called pulmonary vascular resistance (PVR) — essentially how hard the heart has to work to push blood through the lung's blood vessels — as well as exercise capacity, breathlessness, and physical functioning over up to 24 weeks. The reported data shows that for the main outcome — PVR measured at 16 weeks and expressed as a percentage of each person's starting value — the macitentan group's average result was 73.0% of their baseline, compared to 87.2% in the placebo group. A lower percentage means the resistance was lower than at the start. For exercise capacity, measured by how far participants could walk in six minutes, the reported data shows the macitentan group started at an average of 353 metres and reached 388 metres at week 24 (a change of about 35 metres), while the placebo group started at 351.2 metres and ended at 352.2 metres (a change of about 1 metre). For breathlessness scored immediately after the walk (on a scale of 0 to 10, where lower is better), the reported change was −0.1 in the macitentan group and +0.3 in the placebo group. Regarding physical functioning class, no participants in either group moved to a worse functional category by week 24, though the data also captured how many stayed the same or improved across categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01338415 · results posted 11 December 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01338415) involved children with pulmonary arterial hypertension (PAH) — a condition where the blood pressure in the arteries leading to the lungs is abnormally high. A total of 64 children took part in the main study periods: 33 were given a medicine called bosentan twice a day, and 31 were given bosentan three times a day. A small separate group of 10 participants went through an additional "exceptional use" period. The trial tracked adverse events (any unwanted health occurrences, whether or not thought to be related to the medicine), as well as changes in how severely the condition affected the children over time. The reported data shows that when it came to adverse events — the primary thing being measured — 29 out of 33 children in the twice-daily group and 26 out of 31 children in the three-times-daily group experienced at least one adverse event during the study. For changes in disease severity (rated on a standard scale from Class I, least severe, to Class IV, most severe) at 12 months, the reported data shows that in the twice-daily group, 7 children improved, 4 worsened, and 22 stayed the same; in the three-times-daily group, 3 improved, 3 worsened, and 25 stayed the same. Similar figures were reported at 18 months. Regarding PAH worsening events (such as hospitalisation, death, or needing new treatment), 10 children in the twice-daily group and 5 in the three-times-daily group experienced at least one such event, while 23 and 26 children respectively did not. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00853112 · results posted 24 October 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people in total across seven groups. Participants were assigned to receive either a placebo (a dummy treatment with no active ingredient), one of five different doses of an investigational medicine called PF-00489791 (1 mg, 2 mg, 4 mg, 10 mg, or 20 mg), or a comparison medicine called sildenafil. Group sizes ranged from 6 to 8 people at the start, and most participants completed the study. The trial was measuring how these treatments affected blood flow through the lungs and around the body, specifically by tracking a measure called Pulmonary Vascular Resistance Index (PVRI) — essentially, how hard the heart has to work to push blood through the lung's blood vessels — as well as a similar measure for the rest of the body (SVRI). The reported data shows that, for the primary measure (average change in PVRI over four hours), the placebo group had a starting PVRI of around 2,027 units and a reported change of approximately −47 units. The reported changes for the PF-00489791 doses were: −107 units (1 mg), +12 units (2 mg), −335 units (4 mg), and −267 units (10 mg). Results for the 20 mg dose and the sildenafil group were not reported in the submitted data for the change values. For the secondary measures, the reported data shows varying changes in PVRI and SVRI at individual hourly time points across the groups, and small changes in a measure of how much blood the heart pumps per minute (Cardiac Index), ranging from around −0.06 to +0.49 units across the groups where data was provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01042158 · results posted 12 September 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people, all of whom received a combination of two medicines — tadalafil and ambrisentan — at the same time (referred to as "upfront therapy"). The trial was looking at changes in the heart and blood vessels over 36 weeks in people with a condition affecting blood pressure in the lungs. Twenty-four of the 25 participants completed the study, and one did not finish. The reported data shows the following numbers before and after the 36-week treatment period. For the two main things being measured: the mass (weight) of the right side of the heart, as measured by a type of heart scan, was reported as 32.5 grams at the start and 28.0 grams at 36 weeks; and the resistance to blood flow through the lungs (measured during a procedure called a right heart catheterisation) was reported as 6.9 "Wood units" at the start and 3.1 Wood units at 36 weeks. For the two additional measurements: the movement of a valve on the right side of the heart (measured by ultrasound) was reported as 2.2 cm at the start and 1.65 cm at 36 weeks; and the distance participants could walk in six minutes was reported as 343 metres at the start and 395 metres at 36 weeks. It is important to note that the data as submitted does not separately label which figures are the "before" and "after" values for each measurement — the two numbers listed per outcome are as they appear in the ClinicalTrials.gov record. No information about statistical analysis or whether differences were considered meaningful was reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02847260 · results posted 8 September 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT02847260) enrolled 39 people who were given a medication called Remodulin (treprostinil) for a condition involving the blood vessels in the lungs (pulmonary hypertension). The trial ran for 16 weeks and was mainly measuring how many participants could complete the full treatment period without experiencing a serious side effect that the doctors thought might be related to Remodulin. Of the 39 who started, 32 finished the study and 7 did not complete it. The reported data shows that 32 out of 39 participants met the main goal — that is, they completed the 16-week period without a serious side effect considered possibly linked to the treatment. For the additional things measured, the reported data shows that on average, participants walked 11.5 metres further in a six-minute walking test at week 16 compared to when they started. Their breathing difficulty score during that walk (rated on a 0–10 scale where higher means more difficulty) showed no average change (0.0). A blood marker linked to heart strain called NT-proBNP dropped by an average of 182 pg/mL (a unit used to measure this substance in the blood). For a physical activity rating scale (WHO Functional Class, ranging from Class I with no limitations to Class IV unable to do any activity without symptoms), the reported data shows 18 participants had no change in their class, 4 improved, and 1 worsened — the remaining figures were not clearly broken down in the submitted data. A quality-of-life questionnaire (CAMPHOR) showed an average improvement of 5 points in the symptoms section and 1 point in another section (where a lower score means better); the remaining CAMPHOR sections were not separately reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01268553 · results posted 1 September 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom completed the study — none dropped out. There was only one group, meaning everyone received the same treatment with no comparison group. The trial was looking at a transition in medication for people with pulmonary arterial hypertension (a condition affecting blood flow through the lungs), and was measuring things like unwanted health events, physical capacity, breathing efficiency, quality of life, and a blood marker linked to heart strain. The reported data shows that all 6 participants were recorded as not experiencing adverse events (unwanted health effects) over the course of the study, and all 6 were also recorded as not experiencing clinical worsening — meaning none met the defined markers of deterioration, such as death, an unplanned hospital stay for their condition, or a significant drop in physical capacity confirmed by testing. In a standard walking test (where participants walk as far as they can in 6 minutes), the reported average change from the start of the study to 12 weeks was an increase of 20 metres. A breathing efficiency measure recorded during exercise testing was reported as 1.2. A quality-of-life score — where lower numbers mean better quality of life on a scale of 0 to 25 — showed a reported change of minus 0.5 (a very small improvement). A blood marker sometimes used to assess heart strain showed a reported change of 14 pg/mL; however, it was not clearly stated in the data whether this represented an increase or decrease from the starting level. It is worth noting that with only 6 participants and no comparison group, the reported figures reflect a very small, single-arm study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00964678 · results posted 8 June 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people, all of whom received a medication called carvedilol. The trial was looking at how this medication affected the right side of the heart — specifically the right ventricle, which is the chamber responsible for pumping blood to the lungs. Six of the 10 participants completed the study, and four did not finish. The main thing the trial measured was a change in how well the right ventricle pumps blood (called "right ventricular ejection fraction"), assessed using heart MRI scans taken at the start of the trial and again at six months. The reported data shows that, on average, the right ventricular ejection fraction changed by 10.4 percentage points over the six months among those measured. For the secondary outcomes — additional things the trial tracked — the reported data shows individual participant changes in the volume of blood remaining in the right ventricle after it pumps (right ventricular end systolic volume, in millilitres) were: 3, 14, 56, 11, 27, and 25. Changes in how far participants could walk in six minutes (measured in feet) were reported as: 45, 160, 35, 5, and 96. Changes in a measure of right heart movement (tricuspid annular plane systolic excursion, measured in centimetres — where a higher number suggests better movement) were: 0.4, −0.08, −0.12, 0.45, and 0.08. No summary averages for these secondary outcomes were reported in the data, only these individual figures. It is worth noting that with only 10 people enrolled and 6 completing the study, this was a very small trial, and the reported figures reflect a limited number of individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02138825 · results posted 5 June 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT02138825) enrolled 147 people in total — 73 received riociguat (also known as Adempas or BAY63-2521) and 74 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring changes in how far participants could walk in six minutes — a standard test used to gauge a person's physical capacity during everyday activity — after 26 weeks of treatment. The trial also tracked clinical worsening, which was a combined measure looking at things like death from any cause, hospitalisation due to worsening heart or lung status, a significant drop in walking distance, or a decline in a standard measure of how limited a person is by their condition (WHO functional class). The reported data shows that, on average, participants in the riociguat group walked approximately 3.63 metres further at 26 weeks compared to where they started, while those in the placebo group walked approximately 15.94 metres less than where they started. Regarding clinical worsening, the reported data shows that 39 out of 73 riociguat participants and 38 out of 74 placebo participants experienced some form of clinical worsening during the study. The data also reported deaths across different phases of the study: in the riociguat group, 8 deaths occurred during the main treatment phase, 1 during a long-term extension phase, and 3 during a follow-up phase; in the placebo group, 3 deaths occurred during the main phase, 8 during the long-term extension (when those participants had switched to riociguat), 3 during follow-up, and 1 death was also recorded. Additionally, serious unwanted medical events during the safety follow-up phase were reported in 18 participants from the riociguat group and 14 from the placebo group, though what those events were is not detailed in the reported data. It is worth noting that a large proportion of participants did not complete the main study phase — 40 in the riociguat group and 35 in the placebo group — and none completed the long-term extension phase, which the trial description indicates was due to the study being terminated early; the reasons for this are not specified in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01338636 · results posted 22 May 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people who had been diagnosed with exercise-induced pulmonary arterial hypertension (PAH) — a condition where blood pressure in the arteries of the lungs rises abnormally during physical activity. Of the 30 who started, 22 completed the trial and 8 did not finish. The trial was measuring changes in several aspects of how the heart and lungs work during peak exercise, as well as how far participants could walk in six minutes. The reported data shows the following average changes from the start of the trial to the end, across the participants who took part. In terms of lung blood pressure during exercise, the average change in mean pulmonary artery pressure (the pressure in the lung's main artery) was −5.2 mmHg, the transpulmonary pressure gradient (the difference in pressure across the lungs) changed by −7.1 mmHg, and the pulmonary capillary wedge pressure (a measure of pressure in a small branch of the lung artery) changed by 2.9 mmHg. The resistance the blood faces when flowing through the lungs changed by −0.9 units, while the ability of the lung blood vessels to expand changed by 0.8 units. The amount of blood the heart pumped per minute during peak exercise changed by 2.3 litres per minute, and the maximum amount of oxygen the body could use during intense exercise changed by 4.4 percentage points compared to what would be predicted for a healthy person. For the secondary outcome, the reported data shows that the average distance participants could walk in six minutes changed by 34.8 metres from the start of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00666198 · results posted 24 April 2017

  According to the results reported on ClinicalTrials.gov, this trial involved 3,337 participants in Japan who were taking sildenafil citrate (brand name Revatio) for pulmonary arterial hypertension — a condition where the blood pressure in the arteries leading to the lungs is abnormally high. This was a single-group study with no comparison group. Of the 3,337 people who started the study, 3,304 completed it, and 33 did not. The study was primarily measuring unwanted medical events that doctors judged to be related to the medication. The reported data shows that out of 3,337 participants, 448 experienced a treatment-related adverse event (an unwanted medical occurrence that a doctor attributed to the medication). Of those, 101 were classed as serious — meaning they led to outcomes such as hospitalisation, a life-threatening experience, or death. Additionally, 196 participants experienced a treatment-related adverse event that was considered unexpected based on the Japanese product information for this medicine. The reported data also shows that these events were broken down by age (57 in one age group, 391 in another), by gender (323 in one group, 125 in another), by disease type, and by how severely the condition affected participants' day-to-day functioning. The specific labels for these subgroups were not fully detailed in the data available, so a complete breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02705807 · results posted 6 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 10 participants, all of whom completed the study with no drop-outs. All participants were given a version of FLOLAN (a medicine used for a serious lung condition affecting blood pressure) mixed with a newer type of diluent — the liquid used to prepare the medication. The trial was measuring a range of things, including how many participants experienced any unwanted medical events (called adverse events, or AEs) and changes in various blood test results over four weeks. The reported data shows that, out of the 10 participants, 2 experienced any kind of adverse event, and 1 experienced a serious adverse event (a more severe or medically significant unwanted event). When looking at the severity of those adverse events, 1 participant had a mild event and 1 had a moderate event — no severe adverse events were reported. For the blood test measurements, the reported data shows average values at the start of the study and again at four weeks. For example, average haemoglobin (a protein in red blood cells that carries oxygen) was reported as 135.5 g/L at the start and 124.1 g/L at four weeks. Other blood counts — including white blood cells, platelets, and the proportions of different types of white blood cells — were also measured at both time points, with the figures showing small numerical differences between the start and the four-week mark. The specific meaning or significance of these changes was not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01642407 · results posted 4 April 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01642407) enrolled 6 participants, all of whom received sildenafil. The trial was studying pulmonary arterial hypertension (PAH) — a condition where the blood pressure in the arteries supplying the lungs is abnormally high. The trial was split into two parts: an initial 16-week period, and a longer follow-up period lasting up to around 120 weeks. Of the 6 people who started Part 1, only 3 completed it and moved into Part 2, and of those 3, only 1 completed Part 2. Because so few people participated, these results should be understood as very limited in scope. The reported data shows several measurements taken before and after 16 weeks of treatment. For the pressure in the lung arteries (called mean pulmonary artery pressure), the starting average was 58.5 mmHg (millimetres of mercury, a standard unit for pressure), and the reported change by week 16 was a decrease of 6.5 mmHg. For a measure of resistance to blood flow through the lungs (called pulmonary vascular resistance index), the starting value was 18.567 wood units·m², with a reported change of −4.113 at week 16. A blood marker linked to heart strain (called BNP) started at an average of 132.62 picograms per millilitre and showed a reported decrease of 64.10 at week 16. Regarding participants' physical functioning (rated on a WHO scale from Class I to Class IV, where higher numbers mean more limitation): at week 16, the reported data shows 1 participant's classification improved, 3 showed no change, and none worsened — though it is worth noting not all 6 participants were assessed at every time point. The reported data shows that this was a very small trial, and the numbers above simply reflect what was recorded and submitted to ClinicalTrials.gov — they do not on their own tell us whether sildenafil works or is safe for PAH. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01470144 · results posted 9 December 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 41 participants, all of whom were in a single treatment group. Of those 41 people, 31 completed the study and 10 did not finish. The trial was measuring unwanted medical events that occurred during treatment (called "treatment-emergent adverse events") as its main focus, and also tracked how long participants were exposed to the treatment being studied (a medicine referred to as EFI). The reported data shows that all 41 participants who started the trial were counted as having experienced at least one treatment-emergent adverse event — in other words, an unwanted medical event that occurred while they were receiving the treatment. It is important to note that this figure simply records that these events were observed and counted; it does not on its own tell us how serious they were or whether the treatment caused them. For the secondary measure, the reported data shows that the average duration of exposure to the treatment across participants was 2.44 years, though no further breakdown of this figure was provided in the submitted data. It should be noted that the submitted results do not include detail about the nature or severity of the adverse events recorded, so those specifics cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00367770 · results posted 15 August 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT00367770) enrolled 37 people, all of whom received a treatment called Tracleer (bosentan). The trial was looking at how participants' physical condition changed over 24 weeks, specifically measuring how far they could walk in six minutes, how breathless they felt during effort (using a numbered scale), and whether their overall disease classification assigned by a doctor changed over that period. Thirty-five of the 37 participants completed the trial, and two did not finish. The reported data shows the following results after 24 weeks. On average, participants' six-minute walk distance changed by 13.5 metres. Their score on the Borg Dyspnoea Index — a scale from 0 (no breathlessness) to 10 (maximum breathlessness) used to rate how hard it feels to breathe — changed by an average of 0.1 units. For the third measure, 13 out of 37 participants were reported to have had a change in their WHO Functional Class (a doctor-assigned rating of how much a condition limits daily activities) from their starting point to week 24. The reported data does not break down how many of those 13 people improved versus worsened, only that a change occurred. No comparison group (such as a placebo group) was included in the data submitted, so these figures reflect the Tracleer group alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01088997 · results posted 12 July 2016

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called milrinone given to newborn babies diagnosed with a condition called Persistent Pulmonary Hypertension of the Newborn (PPHN) — where blood pressure in the lungs is abnormally high after birth. Twelve babies took part in total: seven were given a higher dose of milrinone and five were given a lower dose. The main thing the trial was measuring was how the babies' bodies processed the drug — specifically, how quickly it was cleared from the bloodstream. The trial also tracked two other measures related to how well the lungs and heart were working during the infusion. The reported data shows that, when looking at drug clearance across all participants combined, the rate at which milrinone left the body was measured at 7.65 mL per minute (adjusted to a standard body weight of 3.4 kg). For the measure of how well the lungs were taking in oxygen (called the Oxygenation Index, where a higher number generally indicates more difficulty), the reported change from the start to up to 24 hours later was 4.9 units in the high-dose group and 36.5 units in the low-dose group. For the heart function measure (called the Myocardial Performance Index, where a lower number is generally considered better), the reported change was −0.12 units in the high-dose group and −0.09 units in the low-dose group. It is worth noting that only 4 babies in the high-dose group and 2 in the low-dose group completed the trial, so the numbers reported are based on a very small group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01588405 · results posted 16 May 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01588405) involved 33 people who had been receiving a medicine called parenteral Remodulin (delivered by injection or infusion) for a lung condition called pulmonary hypertension. The study tested whether these participants could be switched over to an oral (tablet) form of the same medicine, called UT-15C SR (oral treprostinil). Thirty-one of the 33 participants completed the study, and two did not finish. The reported data shows that all 31 participants who completed the study were counted as having successfully made the switch to the tablet form by week four and remained on it through week 24 — this was the main thing the trial set out to measure. For the secondary measurements, the reported data shows that participants' average distance walked in a standard six-minute walking test was 467 metres at the start, with an average change of 16.7 metres by week 24. Breathing difficulty (rated on a 0–10 scale immediately after the walk, where 0 means no shortness of breath) showed a reported change of 0.0 points from the start to week 24. A quality-of-life questionnaire (the CAMPHOR, where lower scores suggest improvement) showed a reported change of −1.0 in the symptoms section, 0.0 in the activity section, 0.0 in the quality-of-life section, and −2.0 in the total score. A separate measure of breathing difficulty and fatigue during daily tasks (the Dyspnea-Fatigue Index, scored 0–12 where higher is better) showed a reported change of +1.0 point from the start to week 24. The reported data shows that participants' physical function category (rated Class I through IV by a doctor, where Class I means no limitation and Class IV means severe limitation) was also tracked, though the breakdown of individual participants across categories at each time point was not fully labelled in the submitted data, so a clear before-and-after comparison cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01106014 · results posted 1 March 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01106014) involved 1,156 people with pulmonary arterial hypertension (a condition where blood pressure in the lungs is abnormally high). Of these, 574 were assigned to receive selexipag and 582 received a placebo (a dummy treatment with no active ingredient). The trial's main goal was to track how long it took before participants experienced a serious health setback — such as being hospitalised due to their condition worsening, needing a lung transplant, starting certain intensive treatments, or dying — for up to seven days after they finished taking the study medication. The reported data shows the percentage of participants who had not yet experienced one of those serious events at various points in time. In the selexipag group, that figure started at 91.2% and fell to 58.2% by the final measured time point. In the placebo group, it started at 81.7% and fell to 41.7% by the same point. For a secondary measure — how far participants could walk in six minutes — the reported data shows that the selexipag group's average walking distance changed by approximately +4 metres from their starting point at week 26, while the placebo group's average changed by approximately −9 metres. For another secondary measure — the proportion of participants whose WHO functional class (a rating of how much their condition limits daily activity) did not worsen by week 26 — the reported figures were 77.8% in the selexipag group and 74.9% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01260454 · results posted 22 February 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, and all 6 completed the study — none dropped out. The trial involved a single group who received the Qutenza patch (which contains a concentrated chilli-pepper-derived substance called capsaicin). The study was measuring pain at the site where a medication called treprostinil is delivered under the skin, using a diary-based pain scale and other related measures over a 14-day period. The reported data shows that, on average, participants rated their daily maximum pain at the infusion site as 2.89 out of 10 on a standard 0–10 pain scale (where 0 means no pain and 10 means the worst imaginable pain). For the secondary measures, the reported data shows that 3 out of 6 participants recorded a pain level above 6 out of 10 at the time the Qutenza patch itself was applied. Additionally, 4 out of 6 participants used some form of narcotic (strong painkiller) at least once during the 14-day diary period following their infusion site change. It is worth noting that this was a very small study with only 6 participants, so the numbers above represent a limited snapshot of experience only. No comparison group was included in the reported results, meaning there are no figures to compare against from this trial alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01104870 · results posted 30 December 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 50 people with pulmonary hypertension (high blood pressure in the lungs) who were split into three groups receiving different doses of a medication called UT-15C. The trial ran for 12 weeks and was mainly measuring changes in how hard the heart and lungs had to work during exercise — specifically a measure called Total Pulmonary Resistance Index (TPRI), which reflects the resistance to blood flow through the lungs. A number of secondary measures were also tracked, including blood pressure in the lungs, heart pumping performance, how far participants could walk in six minutes, breathing difficulty, and symptom severity. The reported data shows that, for the primary measure (lung resistance during exercise), the three dose groups started at similar levels and the changes over 12 weeks were small: Dose Group 1 showed a change of −0.49 units, Dose Group 2 showed a change of +0.56 units, and Dose Group 3 showed a change of −2.02 units (in the relevant measurement units). For the six-minute walk test — where participants walked as far as they could in six minutes — the reported distances increased in all three groups from the start to week 12: Dose Group 1 went from about 362 metres to 408 metres (a change of +46 metres), Dose Group 2 from 338 to 357 metres (+19 metres), and Dose Group 3 from 318 to 350 metres (+32 metres). The reported data shows that breathing difficulty scores and symptom severity scores changed only slightly or not at all across the groups over the 12 weeks. For the heart-related measures, the reported data shows lung artery pressure and heart pumping performance remained broadly similar from the start to week 12 across all three groups, with only small numerical changes recorded. It is worth noting that this trial was not designed with a placebo (inactive treatment) comparison group, so these numbers reflect changes within each dose group over time only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01392495 · results posted 13 July 2015

  According to the results reported on ClinicalTrials.gov, this trial investigated a drug called QTI571 and enrolled 17 participants in total. Four participants received a lower dose of 200 mg, and 13 received a higher dose of 400 mg. The trial was primarily looking at unwanted or harmful events (called adverse events), serious adverse events, and deaths that occurred during the study. Secondary measures included changes in how far participants could walk in six minutes, how long it took for their condition to get worse, and how much medical care they used during the trial. The reported data shows that when it came to adverse events (any unwanted health events noted during the trial), all 4 participants in the 200 mg group and all 13 in the 400 mg group experienced at least one. For serious adverse events (those considered more significant or life-threatening), 4 out of 4 in the 200 mg group and 5 out of 13 in the 400 mg group were recorded. Deaths were reported for 2 participants in the 200 mg group and 1 in the 400 mg group. Only 1 participant out of the 17 completed the study, while 16 did not complete it; the reasons for this were not detailed in the submitted data. For the secondary outcome measures — the six-minute walk distance, time to worsening, and medical resource use — the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of these measures, so those findings cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01808313 · results posted 12 May 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 133 participants, all of whom received the study medicine, ambrisentan. Of those, 123 completed the study and 10 did not. The trial was measuring several things in people with pulmonary arterial hypertension (a condition affecting blood pressure in the lungs), including how far participants could walk in six minutes, how breathless they felt after walking, levels of a certain protein in the blood linked to heart strain, their overall physical ability rating (called a WHO functional class, a scale doctors use to grade how much a condition limits daily activity), and whether their condition got worse over time. The reported data shows that, on average, participants walked about 54 metres further in the six-minute walk test at week 12 compared to when they started, and about 64 metres further at week 24. For the breathlessness score after walking (rated 0–10, where lower is better), the reported average change was a small decrease of 0.34 points at week 12 and 0.22 points at week 24. Regarding the WHO functional class at week 12, the reported data shows 44 participants improved by one category, 84 stayed the same, 4 worsened by one category, and 1 worsened by two categories; at week 24, 51 improved by one category, 77 stayed the same, 3 worsened by one category, and 2 worsened by two categories. For the heart-strain protein (NT-proBNP), the reported figures are expressed as a mathematical transformation (log scale) and showed a change of 0.44 at week 12 and 0.37 at week 24. Regarding disease worsening events up to week 24, the reported data shows 3 participants were hospitalised for PAH treatment, 1 stopped the study medicine due to switching to another PAH treatment, and 2 deaths were recorded; no lung transplants or certain other procedures were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01178073 · results posted 28 April 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01178073) enrolled 605 people with pulmonary arterial hypertension (PAH) — a condition involving high blood pressure in the arteries of the lungs. Participants were divided into three groups: 302 received a combination of two medicines (ambrisentan and tadalafil together), 152 received ambrisentan alone, and 151 received tadalafil alone. The main thing the trial was measuring was how many people in each group experienced a first "clinical failure" event — meaning death, a hospital stay due to worsening PAH, the disease getting worse in other ways, or an unsatisfactory long-term response to treatment — over the course of the study. The reported data shows that, for the primary outcome, 46 out of 302 people (roughly 15%) in the combination therapy group experienced a clinical failure event, compared with 77 out of 303 people (roughly 25%) across the two single-medicine groups combined (43 in the ambrisentan-alone group and 34 in the tadalafil-alone group). For the secondary outcomes at 24 weeks, the reported data shows that a blood marker related to heart stress (called NT-proBNP) changed by −67% in the combination group versus −50% in the pooled single-medicine group. The percentage of participants recorded as having a "satisfactory clinical response" at 24 weeks was 39% in the combination group, 31% in the ambrisentan-alone group, and 27% in the tadalafil-alone group. The reported data also shows that the distance participants could walk in six minutes increased by about 49 metres in the combination group and about 24 metres in the pooled single-medicine group from the start of the trial. Changes in breathlessness scores and a functional severity scale showed small numerical differences between groups, as reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01389856 · results posted 23 March 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 21 newborn babies in total — 13 received bosentan (an oral medicine) and 8 received a placebo (a dummy treatment with no active ingredient). All 21 babies completed the study with no dropouts. The trial was looking at whether bosentan could help babies who needed inhaled nitric oxide (iNO) — a gas delivered through breathing support — to be weaned off that treatment. It measured things like how long it took to come off the gas, how long it took to come off the breathing machine, and whether any babies needed to be escalated to more intensive treatments. The reported data shows that for the main (primary) outcomes, 7.7% of babies in the bosentan group experienced "treatment failure" (meaning they needed a more intensive intervention such as a heart-lung bypass machine or a different lung medicine), compared with 0% in the placebo group. The average time to fully wean off inhaled nitric oxide was reported as 3.7 days in the bosentan group and 2.9 days in the placebo group. The average time to come off the breathing machine was 10.8 days in the bosentan group and 8.6 days in the placebo group. For the secondary outcomes, 0% of babies in either group needed the inhaled nitric oxide to be restarted after it was stopped. Around 41.7% of babies in the bosentan group and 37.5% in the placebo group still showed signs of raised pressure in the lungs at the end of treatment, as measured by an ultrasound of the heart. The trial also tracked a measure of how well the lungs were putting oxygen into the blood (called the oxygenation index); the reported data shows a small change in this measure over time in both groups, though the figures across the different time points are listed separately in the data without a clear summary label for each. It is worth noting that this was a very small trial with only 21 participants, which limits how much can be read into the numbers. The reported data shows differences between groups in some measures, but the trial was not large enough to draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01148836 · results posted 20 March 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people in total — 8 healthy volunteers and 10 people diagnosed with pulmonary hypertension (a condition where blood pressure in the lungs is abnormally high). By the end of the study, 7 healthy volunteers and 8 pulmonary hypertension participants had completed it. The trial was measuring several aspects of how the heart was functioning, particularly on the right side of the heart, using ultrasound-based heart assessments. The reported data shows the following numbers for the pulmonary hypertension group across the primary measures (two sets of figures are listed for each measure, likely representing different time points, though the data as submitted does not label these time points explicitly): the amount of blood in the left heart chamber at rest was reported as 81 ml and 70 ml; a measure of blood flow out of the right side of the heart (recorded as a distance the blood travels) was 11.3 cm and 13.5 cm; a score reflecting how well the right side of the heart was performing overall was 0.9 and 0.7 (on a ratio scale); a grading of a heart valve called the tricuspid valve (on a scale of 1 being normal to 4 being severe) was reported as 1.4 and 1.2; and the pressure in the right upper chamber of the heart was reported as 10 mmHg and 8 mmHg. For the secondary measure — red blood cell count — the pulmonary hypertension group returned figures of 5.2 at both time points, while the healthy control group returned 4.5 and 4.3 (measured in millions of cells per microlitre of blood). The reported data does not include explanations for what each pair of figures represents (for example, whether they reflect a before-and-after comparison), so that context is not available from the submitted results. No comparison figures between the two groups were reported for the primary heart measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01801982 · results posted 10 December 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01801982) enrolled just one participant, who received sildenafil. The trial was a long-term follow-up study looking at participants who had previously taken part in an earlier related study. It was designed to track their health over two years by checking for any unusual findings on physical examination and any notable medical history (such as hospital admissions or new medications), as well as monitoring whether participants were still alive at the 12- and 24-month marks. The reported data shows that at the 12-month point, zero out of the one participant had any physical examination abnormalities recorded, and zero had any clinically significant medical history events. For overall survival at 12 months, the reported data shows the one participant was alive. For all of the 24-month outcome measures — physical examination abnormalities, clinically significant medical history, and overall survival — no data was reported, which the trial records indicate is because the single participant did not complete the study. It is worth noting that with only one participant enrolled, and that person not completing the study, the reported numbers are extremely limited and do not allow for any broader conclusions to be drawn. The reported data shows only what was observed for this single individual up to the 12-month check-in. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01072643 · results posted 8 September 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 4 participants, all of whom completed the study. It was investigating the use of a sedative medicine called dexmedetomidine (DEX) in children with a condition called pulmonary hypertension — a term for higher-than-normal blood pressure in the blood vessels of the lungs. The main thing being measured was how DEX affected a value called pulmonary vascular resistance (PVR), which is a measure of how much resistance there is to blood flowing through the lungs. PVR is expressed in "Wood units," where a higher number means more resistance. The reported data shows PVR measurements taken at different time points for each of the 4 participants. For Subject 1, the readings were 8.9, 9.7, and 7.1 Wood units. For Subject 2, they were 13.7, 15.5, and 15.5 Wood units. For Subject 3, they were 5.45, 6.52, and 7.0 Wood units. For Subject 4, they were 8.57, 13.18, and 2.27 Wood units. The trial was stopped early because, in one participant, the PVR rose between two measurement points to a level that triggered a pre-set stopping rule — meaning the researchers had decided in advance that if this happened, the trial should not continue. For the secondary outcome measures — including data on how well the sedation worked, how the drug moved through the body, and other assessments — no numerical results were reported on ClinicalTrials.gov. The reported data notes that the investigators stated it would be premature to draw conclusions about whether DEX does or does not negatively affect lung blood pressure, given how few participants were enrolled before the trial was stopped. No conclusions about the medicine's usefulness or safety can be drawn from a trial of this size, and none are made here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02170519 · results posted 26 August 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT02170519) looked at inhaled iloprost — a medication delivered by breathing it in — in two phases. Phase 1 involved 5 participants who received three separate doses, and Phase 2 involved 22 participants who received a continuous (ongoing) dose. All participants in both phases completed the study. The trial was measuring three things at various time points: the percentage change in blood oxygen levels (how much oxygen is in the blood, measured as "SpO2"), the percentage change in heart rate, and the percentage change in cardiac output (how much blood the heart pumps per minute). The reported data shows the following for Phase 2 (continuous dosing, 22 participants): blood oxygen levels changed by amounts ranging from about −1.5% to +1.7% across the different time points measured. Heart rate changed by amounts ranging from approximately −9.9% to +4.2% across those same time points. Cardiac output (the volume of blood pumped by the heart) changed by amounts ranging from about +3.4% to +36.6% across the time points. For Phase 1 (three doses, 5 participants): blood oxygen level changes ranged from −0.4% to +0.4%, heart rate changes ranged from −0.2% to +2.5%, and cardiac output changes ranged from −8.7% to +8.7% across the measurement points. No overall group summary figures (such as averages) were included in the submitted data, only individual time-point readings. It is worth noting that the trial's own data description mentions that readings were taken from medical records and may not always have been recorded at the exact intended time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01330108 · results posted 11 August 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people, all of whom received a medication called ambrisentan. The trial was looking at how many participants were unable to tolerate (that is, could not continue taking) ambrisentan within the first 12 weeks, and also measured whether participants' ability to walk changed over that period. By the end of the study, 28 people had completed it, and 4 did not. The reported data shows that 4 out of 32 participants were recorded as not being able to tolerate ambrisentan — meaning they experienced a side effect or unwanted reaction that was unacceptable to them, and were switched back to their previous medication. For the secondary outcome, the trial measured how far each participant could walk in six minutes at the start of the study compared to 12 weeks later. The reported data shows an average (mean) distance of 368.71 metres at 12 weeks. However, it is important to note that the starting (baseline) figure was not separately reported in the structured results, so it is not possible from this data alone to describe how much the walking distance may have changed from the beginning of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00660179 · results posted 5 May 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT00660179) involved 742 people with pulmonary arterial hypertension (a condition where blood pressure in the arteries supplying the lungs is abnormally high). Participants were divided into three groups: 250 received a placebo (a dummy treatment with no active ingredient), 250 received a 3 mg dose of ACT-064992 (also known as macitentan), and 242 received a 10 mg dose of ACT-064992. The trial's main focus was tracking how long it took before participants experienced a serious health setback — such as death, a lung transplant, or a significant worsening of their condition — or remained free of such events. The reported data shows that, using a statistical method called Kaplan-Meier estimation (which tracks how many participants remained event-free over time), the proportion of participants who had not experienced a serious worsening event differed across the three groups at various time points during the study. For the primary outcome, by around the end of the full treatment period, the reported figures were approximately 57% for the placebo group, 66% for the 3 mg group, and 74% for the 10 mg group remaining free of such events. For a secondary measure — remaining free of death specifically related to the lung condition or hospitalisation for it — the reported figures at a similar time point were approximately 68% (placebo), 75% (3 mg), and 82% (10 mg). Regarding the six-minute walk test (how far someone can walk in six minutes), the reported average change from the starting point to six months was a decrease of about 9 metres in the placebo group, compared to an increase of about 7 metres in the 3 mg group and about 13 metres in the 10 mg group. The reported data also shows that 32 participants in the placebo group, 49 in the 3 mg group, and 54 in the 10 mg group showed an improvement in their physical functioning category (rated by doctors on a scale from Class I to Class IV) at six months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00879229 · results posted 22 April 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT00879229) enrolled 40 people in total — 25 received ambrisentan and 15 received a placebo (a dummy treatment with no active ingredient). The trial was measuring several things over 16 weeks, with the main focus being how far participants could walk in six minutes (known as a "six-minute walk test"), which is a common way of measuring physical capacity in people with lung conditions. It is worth noting that very few participants completed the full study — only 3 in the ambrisentan group and 1 in the placebo group finished — and the data was not reported as to why so many did not complete it. The reported data shows that both groups walked shorter distances at week 16 compared to when they started. On average, those in the ambrisentan group walked 96 metres less than at the start, while those in the placebo group walked 67 metres less. For long-term survival (estimated up to 48 weeks using a statistical method that accounts for people who left the study early), the reported probability of survival was 22% for the ambrisentan group and 23% for the placebo group. A breathlessness rating scale (scored from −9 to +9, where lower means more breathlessness) showed a change of −1.5 for the ambrisentan group and −1.4 for the placebo group — meaning both groups reported slightly more breathlessness than at the start. For two other secondary measures — lung function (FVC) and a heart-related blood marker (NT-proBNP) — no numerical results were reported in the submitted data. The WHO functional class (a 1–4 scale rating severity, where 4 is worst) showed mixed changes across both groups, but the way the data was presented in the submission makes a straightforward plain-language summary difficult without risk of misrepresentation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00855465 · results posted 11 March 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT00855465) enrolled 262 people in total — 174 in the riociguat (Adempas) group and 88 in the placebo (dummy pill) group. The trial was measuring how riociguat compared to a placebo over 16 weeks in people with a condition affecting blood pressure in the lungs (pulmonary hypertension). The main thing being measured was how far participants could walk in six minutes — a standard way of assessing physical fitness capacity in this condition. A number of secondary things were also tracked, including blood vessel resistance in the lungs, a blood marker linked to heart stress, how participants felt during exercise, their overall physical functioning category, and whether their condition got noticeably worse. The reported data shows that, for the primary measure — change in six-minute walking distance after 16 weeks — the riociguat group's average distance increased by about 39 metres, while the placebo group's average distance decreased by about 5.5 metres. For the secondary measures, the reported data shows that resistance in the lung blood vessels (pulmonary vascular resistance) changed by approximately −226 units in the riociguat group compared with +23 units in the placebo group. A blood marker of heart stress (NT-proBNP) changed by approximately −291 units in the riociguat group versus +76 units in the placebo group. A breathlessness rating scale (scored 0–10, where lower means less effort reported) changed by −0.83 in the riociguat group versus +0.17 in the placebo group. Regarding clinical worsening — a combined measure looking at serious events such as hospitalisation or needing new treatment — approximately 2.3% of the riociguat group and 5.7% of the placebo group experienced this outcome. The WHO functional class data (a rating of physical limitation, from Class I being least affected to Class IV being most affected) was also reported but the submitted data contained multiple overlapping figures that could not be clearly separated, so a full plain breakdown of that measure cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00640315 · results posted 28 February 2014

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called riociguat (also known as Adempas or BAY63-2521) in people with pulmonary hypertension — a condition involving high blood pressure in the arteries of the lungs. A total of 23 people took part: 10 received a lower dose of 1.0 mg and 13 received a higher dose of 2.5 mg. All 23 participants started and received treatment, and 22 completed the study (one person in the 2.5 mg group did not finish). The trial measured how the drug moved through the body (pharmacokinetics) and how it affected blood pressure and resistance in the lung's blood vessels, measured through a procedure called right heart catheterisation. The reported data shows that, on the first day of treatment, the average pressure in the main lung artery (mean pulmonary artery pressure) changed from its starting point by minus 3.60 mmHg in the 1.0 mg group and minus 4.83 mmHg in the 2.5 mg group — meaning the recorded pressure was lower after taking the medicine than before. The resistance to blood flow in the lung's arteries (pulmonary vascular resistance) also showed a recorded change from the starting point of minus 58.32 units in the 1.0 mg group and minus 123.8 units in the 2.5 mg group. Separately, the trial tracked how much of the drug and one of its breakdown products (called metabolite M1) were present in participants' blood over time. The reported data shows the total amount of riociguat measured in the blood was 481.9 µg·h/L for the 1.0 mg group and 1,319 µg·h/L for the 2.5 mg group, with the peak blood concentration reaching 42.96 µg/L and 116.0 µg/L respectively. Some measurements for the 1.0 mg group were not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00810693 · results posted 26 February 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 445 people in total across three groups: 254 received riociguat (Adempas) at a dose of up to 2.5 mg, 64 received riociguat at a lower dose of up to 1.5 mg, and 127 received a placebo (a dummy treatment with no active ingredient). The trial was studying a condition called pulmonary arterial hypertension — high blood pressure in the arteries of the lungs — and ran for 12 weeks. The main thing being measured was how far participants could walk in six minutes, which is a standard way of gauging a person's physical capacity. A number of other things were also tracked, including blood pressure resistance in the lung arteries, a heart-stress marker in the blood, how participants rated their own breathlessness during exercise, and how many people experienced a significant health setback during the trial. The reported data shows that, for the primary measure — change in six-minute walking distance from the start to week 12 — the higher-dose riociguat group recorded an average increase of about 30 metres, the lower-dose group recorded an average increase of about 31 metres, and the placebo group recorded an average decrease of about 6 metres. For the secondary measures, the reported data shows that lung artery resistance (a technical measure of how hard the heart must work to push blood through the lungs) changed by an average of −223 units in the higher-dose group, −168 units in the lower-dose group, and −9 units in the placebo group — where a lower number means less resistance. A blood marker linked to heart stress (NT-proBNP) changed by an average of −198 units in the higher-dose group, −472 units in the lower-dose group, and increased by +232 units in the placebo group. On a scale of 0–10 measuring how hard participants felt they were breathing during exercise (the Borg scale), the higher-dose group reported a change of −0.44, the lower-dose group −0.33, and the placebo group +0.09. Regarding significant health setbacks during the trial, the reported data shows that 1.2% of the higher-dose group, 3.2% of the lower-dose group, and 6.3% of the placebo group experienced what was classed as clinical worsening overall, though the data was broken down across several sub-categories. Functional class (a doctor's rating of how limited a person is by their condition) data was also reported across categories, but the individual category breakdowns are complex and the overall pattern across groups was not summarised as a single figure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01065454 · results posted 25 December 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 201 people in total across four groups: 67 received riociguat (Adempas) at doses up to 2 mg, 33 received it at doses up to 1 mg, 32 received a fixed 0.5 mg dose, and 69 received a placebo (an inactive treatment used for comparison). The trial was measuring changes in blood pressure inside the lungs and related measures of how blood flows through the heart and lungs, assessed over 16 weeks using a procedure called a right heart catheterisation — a test where a thin tube is guided into the heart to measure pressures directly. The reported data shows that the main thing being measured was the average pressure in the main lung artery (called mean pulmonary arterial pressure). At the end of 16 weeks, all four groups showed a reduction from their starting values: the up-to-2 mg riociguat group had an average reduction of 6.1 mmHg (millimetres of mercury, a unit of pressure), the up-to-1 mg group had a reduction of 0.8 mmHg, the fixed 0.5 mg group had a reduction of 4.5 mmHg, and the placebo group had a reduction of 4.0 mmHg. The reported data also shows changes in several secondary measures — including resistance to blood flow in the lungs and in the body more broadly — where all groups, including the placebo group, showed reductions from their starting points over the 16 weeks. The reported data also shows changes in the oxygen level in mixed venous blood (blood returning to the heart): the up-to-2 mg group rose by 1.98 percentage points, the up-to-1 mg group by 0.46 points, the fixed 0.5 mg group fell slightly by 0.21 points, and the placebo group rose by 1.28 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00323297 · results posted 19 November 2013

  According to the results reported on ClinicalTrials.gov, this trial looked at sildenafil as a treatment for pulmonary arterial hypertension (PAH) — a condition involving high blood pressure in the arteries that supply the lungs. The trial had two parts: a double-blind phase (where neither participants nor researchers knew who was getting which treatment) and an open-label phase (where everyone knew). In Part A, 53 people received a placebo (a dummy treatment with no active ingredient) and 50 received sildenafil. Of those, 48 and 43 respectively went on to Part B. The main thing being measured was how far participants could walk in six minutes — a common way of checking physical capacity — after 12 weeks of treatment. The reported data shows that, on average, the placebo group increased their six-minute walking distance by about 17 metres from the start of the trial, while the sildenafil group increased theirs by about 14 metres. Regarding breathlessness (rated on a 0–10 scale called the Borg scale), the placebo group's score changed by approximately +0.16 (slightly worse), while the sildenafil group's score changed by approximately −0.73 (slightly better). For most participants in both groups, their WHO functional class — a rating of how much their condition limits daily activity — stayed the same over 12 weeks. A small number experienced clinical worsening events such as hospitalisation; 2 participants in each group were hospitalised due to PAH. One person in the sildenafil group died during the double-blind phase; 2 deaths were recorded in each group over the one-year follow-up period. The reported data also shows that, looking at one-year survival from the point each participant started taking sildenafil, the estimated probability of dying within that year was approximately 0.042 (about 4 in 100) for those who had originally been on placebo, and approximately 0.040 (about 4 in 100) for those originally on sildenafil. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00325442 · results posted 10 June 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 350 people with pulmonary arterial hypertension (a condition affecting blood pressure in the lungs) — 176 in the placebo group (a dummy treatment with no active ingredient) and 174 in the active treatment group. The main thing the trial was measuring was how far participants could walk in six minutes, which is a standard way of assessing physical fitness in this condition. A number of other things were also tracked, including breathlessness during the walk, fatigue, and whether participants' condition got significantly worse over the 16-week study period. The reported data shows that at the start of the study, both groups walked about 362.5 metres on average in six minutes. By week 16, the placebo group's average had risen slightly to about 367 metres, while the active treatment group's average rose to about 381 metres — a reported change of roughly 4.8 metres in the placebo group and 14.5 metres in the active group. At week 12, similar figures were reported (about 5.8 metres change in the placebo group and 16.5 metres in the active group). For breathlessness during the walk (scored 0–10, where higher means more breathless), the placebo group's score went up slightly (from 4.26 to 4.64), while the active group's score stayed roughly the same (from 4.22 to 4.18). For clinical worsening — a combined measure covering death, transplant, hospitalisation, or significant decline — 12 people in the placebo group and 8 in the active group met that definition. The dyspnea-fatigue index (a 0–12 scale where higher is better) showed little change in either group. The reported data for WHO functional classification (a measure of how limited daily activity is) showed broadly similar distributions between the two groups at the end of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00741819 · results posted 20 February 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 73 people who were already taking an inhaled medication called iloprost for pulmonary arterial hypertension (a condition that causes high blood pressure in the lungs). The trial then switched them to a different inhaled medication called treprostinil, and followed them for 12 weeks. The main thing the trial was measuring was the number of unwanted or unexpected health events (called adverse events) that occurred during this switch. Of the 73 people who started, 65 completed the trial and 8 did not finish. The reported data shows that across the study, a total of 440 adverse events were recorded (broken down further as 266, 41, and 15 in additional sub-categories, though the labels for those sub-categories were not included in the data provided). For the secondary measures, participants could walk an average of 392.5 metres in six minutes at the start of the study, and this figure increased by an average of 16 metres by week 12. On the quality-of-life questionnaire (CAMPHOR, scored 0–80 where lower is better), the average starting score was 16.8, and it decreased by 6.4 points by week 12. On the patient satisfaction questionnaire (TSQM, scored 0–100 where higher is better), scores across the four categories sat between roughly 81.9 and 84.4 at the start, with changes ranging from a small decrease of 0.5 points to an increase of 38.3 points by week 12 — the largest change being in the "Convenience" category. The reported data also shows that 73%, 91%, and 94% of participants gave positive responses to the three questions about their overall impression of the transition (the specific wording of each question was not included in the submitted data). A blood marker related to heart strain (NT-proBNP) decreased on average by 74 pg/mL (picograms per millilitre) from the start to week 12. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00549302 · results posted 18 February 2013

  According to the results reported on ClinicalTrials.gov, this trial looked at two doses of a medicine called tadalafil (20 mg and 40 mg) in people with pulmonary arterial hypertension (PAH) — a condition where the blood pressure in the arteries supplying the lungs is abnormally high. The trial had two phases: a double-blind phase (where neither participants nor doctors knew which dose was being given) and an open-label phase (where everyone knew the dose being used). A total of 63 people started in the 20 mg double-blind group and 294 in the 40 mg double-blind group, with 286 going on to the open-label phase at 40 mg. The trial's primary focus was on recording adverse events (unwanted health changes that occurred during the study), and it also measured physical exercise capacity and disease severity over time. The reported data shows that, across the combined double-blind and open-label groups, 184 participants experienced serious adverse events and 334 experienced non-serious adverse events (full details are noted as being available in a separate section of the trial record). For the exercise test — where participants walked as far as they could in 6 minutes — the reported average distances at the start of the double-blind phase were about 398 metres for the 20 mg group and 375 metres for the 40 mg group. By week 52, those averages were reported as approximately 415 metres and 394 metres respectively. For breathlessness during the walk (rated on a 0–10 scale), scores stayed broadly similar across both groups throughout the study. Regarding disease severity, the reported data shows that at week 16 approximately 95% of the 20 mg group and 96% of the 40 mg group had not worsened in their disease classification; by week 52 those figures were reported as approximately 81% and 85% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00373360 · results posted 7 January 2013

  According to the results reported on ClinicalTrials.gov, this trial involved 10 participants, all of whom received a medicine called treprostinil sodium. All 10 participants completed the study — none dropped out. The trial was measuring several things over an 8-week period, with the main focus being how far participants could walk in 6 minutes (known as the "6-minute walk test"), which is a common way of measuring physical capacity in people with a lung condition called pulmonary arterial hypertension (PAH). The reported data shows that, on average, the distance participants could walk in 6 minutes changed by negative 2.2 metres from the start of the trial to week 8 — meaning the average distance walked was very slightly lower at week 8 than at the beginning. For one of the secondary measures, a breathlessness rating scale (scored from 0, meaning no breathlessness, to 10, meaning the worst breathlessness ever felt), the reported average score increased by 1.56 points. For the WHO functional classification — a 4-level rating of how much a condition limits daily activity — the reported data shows that at week 8, 11% of participants were in Class I (no limitation) and 89% were in Class II (slight limitation); no participants were recorded in the more severe classes at that time point. For the symptom measures (breathlessness, fluid swelling, and difficulty breathing when lying flat), the data was reported as percentages across different severity categories, though the exact baseline figures to compare against were not reported in the submitted results, so the direction of change for these measures cannot be determined from the available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00709098 · results posted 29 October 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT00709098) looked at iloprost, a medicine delivered by inhalation, across two phases. In the first phase (the "double-blind period," where neither participants nor researchers knew which version of the device was being used), 25 people used a lower-powered inhaler device (called "Power 6") and 24 used a higher-powered device ("Power 15"). In the second phase (the "open-label period," where everyone knew which device was being used), 32 participants used the higher-powered device. The trial's main focus was on recording unwanted or unexpected health events — known as adverse events — that occurred during the study, rather than measuring how well the medicine worked. The reported data shows that during the double-blind period, the group using the lower-powered device experienced 148 adverse events in total, while the higher-powered device group experienced 139. Serious adverse events — meaning more significant health concerns — were reported at 11 in each of those two groups. When it came to adverse events that led a participant to stop taking the study medicine early, the lower-powered group recorded 3 such events (affecting 2 participants), while the higher-powered group recorded 10 such events (affecting 6 participants). During the open-label period, 126 adverse events, 10 serious adverse events, and 7 events leading to stopping the medicine (affecting 7 participants) were reported. The reported data also shows that the average inhalation time per session was about 10.9 minutes with the lower-powered device and about 5.8 minutes with the higher-powered device. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01105117 · results posted 23 August 2012

  According to the results reported on ClinicalTrials.gov, this trial compared two medications — ACT-385781A (a form of epoprostenol for injection) and Flolan® (another form of epoprostenol sodium for injection) — in people with pulmonary arterial hypertension (a condition involving high blood pressure in the arteries of the lungs) who had not previously been treated with this type of injectable medicine. Only 1 participant was enrolled in each group, giving a total of 2 participants across the whole study. Both participants completed the study. The reported data shows that the trial's primary focus was on safety and tolerability — in other words, how well each treatment was tolerated and whether any serious problems occurred. Two specific things were measured: the number of participants who stopped treatment early due to an unwanted side effect, and the number of deaths. The reported data shows that in both groups, zero participants stopped treatment due to side effects, and zero deaths were recorded. No other outcome measures were reported in the submitted results. It is worth noting that with only one participant per group, the numbers reported here are very limited, and no broader conclusions can be drawn from such a small sample. The reported data does not include any secondary outcome measures, as none were submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00811018 · results posted 24 April 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,192 participants, all of whom received the study drug sitaxsentan. A total of 224 participants completed the trial, while 968 did not complete it. The trial was primarily measuring how often participants experienced adverse events (unexpected or unwanted health occurrences) and serious adverse events, as well as looking at certain blood test results — specifically liver-related markers and general blood and chemistry panels — to track any notable changes from normal ranges. The reported data shows that out of 1,192 participants who started the trial, 1,150 experienced at least one adverse event, and 586 experienced at least one serious adverse event. Regarding liver enzyme readings (ALT and AST, which are markers measured in blood to monitor liver health), the reported data shows that between roughly 0.76% and 5.12% of participants had individual liver enzyme levels rise to more than three times the upper boundary of the normal range at various measurement points, and between approximately 0.67% and 3.94% had both enzymes elevated at the same time. For total bilirubin (another liver-related blood marker), between about 5% and 10.23% of participants recorded levels above one-and-a-half times the upper normal limit. The blood count and general chemistry panels showed a wide range of abnormality rates across different individual tests, with figures spanning from 0% to 100% depending on the specific measurement — though the data as submitted does not label each individual figure to a named test, so a full breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00796510 · results posted 20 February 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT00796510) was set up to study two groups of people with pulmonary arterial hypertension (a condition where blood pressure in the lungs is abnormally high): one group receiving a medicine called sitaxsentan, and another receiving sitaxsentan combined with sildenafil. The trial aimed to measure how long participants survived, how far they could walk in six minutes (a common way of gauging physical fitness in this condition), and what level of disease severity they fell into according to World Health Organization categories. According to the reported data, only three participants were enrolled — all in the sitaxsentan-only group — and none of them completed the study. No participants at all were recorded as starting in the sitaxsentan-and-sildenafil group. The reported data shows that no numerical results were submitted for any of the outcome measures — not for overall survival, not for the six-minute walk distance, and not for the WHO functional class categories. Because the trial enrolled so few people and no one completed it, the data for these measurements was not reported on ClinicalTrials.gov. It is not possible to describe what the trial found on any of these measures, as the figures simply are not there. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00554619 · results posted 13 February 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 21 participants who all received the investigational medicine GSK1325760A. The trial was looking at people with pulmonary arterial hypertension (a condition involving high blood pressure in the arteries that supply the lungs). Of the 21 who started, 18 completed the study and 3 did not. The trial tracked a range of measurements over a period of up to about three years, including how far participants could walk in six minutes, how breathless they felt after that walk, the pressure in their lung arteries, their overall severity rating according to a standard medical classification, and whether any serious events such as hospitalisation or death occurred. The reported data shows that all 21 participants experienced at least one adverse event (an unexpected medical occurrence that happened during the trial, which may or may not have been related to the medicine). For the six-minute walk distance — a measure of how far someone can walk in six minutes — the reported average change from the starting point ranged from roughly 46 to 60 metres higher across the various time points measured. For the breathlessness score (rated on a 0–10 scale after the walk), the reported average changes from the starting point were mostly small and on the negative side (meaning lower scores, i.e. less breathlessness), ranging from about −1.3 to −0.6 at most time points, though two later time points showed small increases of around 1.2–1.3. The reported average change in lung artery pressure ranged from about −5 to −14 millimetres of mercury (a unit used to measure pressure) below the starting level across the time points. Regarding serious worsening events, the reported data shows that 1 participant discontinued due to a change to other treatment, and no participants experienced death, lung transplantation, hospitalisation for the condition, or a surgical heart procedure during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00995566 · results posted 1 February 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT00995566) was a registry study that enrolled 54 participants, all of whom were patients taking a medicine called Thelin (sitaxentan) for pulmonary arterial hypertension — a condition where blood pressure in the arteries leading to the lungs is abnormally high. The study was designed to monitor and record information about participants over time, including liver-related blood test results, changes in blood levels, and any unwanted health events that occurred while taking the medicine. Notably, the data shows that none of the 54 participants were recorded as having "completed" the study, with all 54 listed under "not completed." The reported data shows that, on average, participants had been taking Thelin for approximately 21.5 months. For one of the liver-related measurements — levels of two specific liver enzymes (ALT and AST, which are markers doctors check to assess liver health) rising to more than three times the upper limit of the normal range — the reported figure was 2.2% of participants. The data for two other planned primary outcomes (changes in haemoglobin, which is the protein in red blood cells that carries oxygen, and changes in bilirubin, a substance produced when red blood cells break down) were not reported in the submitted results. Regarding unwanted health events, the reported data shows figures of 11, 1, 6, and 1 participants across different categories of adverse events (such as serious versus non-serious, and whether or not they were considered related to the treatment), though the submitted data does not clearly label which number corresponds to which specific category. The reported data for participants' overall clinical status (whether their condition stayed stable, improved, or worsened) was also not included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00380068 · results posted 19 November 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 224 people, all of whom received a medicine called ambrisentan. There was no comparison group. Of the 224 who started, 155 completed the trial and 69 did not finish. The trial was measuring several things over 24 and 48 weeks, including how far participants could walk in six minutes, how breathless they felt during exertion, a blood marker related to heart stress (called BNP), and their overall physical function category as rated by the World Health Organization (WHO). The reported data shows that, on average, participants walked about 20.5 metres further at 24 weeks compared to when they started. For breathlessness — measured on a 0-to-10 scale where 0 means no breathlessness and 10 means maximum — the average score changed by minus 0.5 points at 24 weeks and minus 0.6 points at 48 weeks. The BNP blood marker (a measure related to heart stress) showed a reported average decrease of 25.5% at 24 weeks and 29.2% at 48 weeks. For the WHO physical function category at 24 weeks, the reported data shows approximately 22.2% of participants improved by at least one category, 70.1% stayed the same, and 6.8% worsened. Some percentage breakdowns within those categories were reported as zero or not separately detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00302211 · results posted 13 August 2010

  According to the results reported on ClinicalTrials.gov, this trial looked at an inhaled medication called iloprost in people with pulmonary arterial hypertension (a condition where the blood vessels in the lungs are under abnormally high pressure). In the main, blinded phase of the trial — where neither participants nor researchers knew who was receiving which treatment — 26 people were assigned to iloprost six times a day, 27 to iloprost four times a day, and 14 to a placebo (an inactive treatment). After this phase, many of those participants continued into an open-label stage (where the treatment was known) involving 26 and 32 people respectively. The trial's main measurement was how far participants could walk in six minutes after 16 weeks of treatment, as a way of assessing their physical capacity. The reported data shows that, after 16 weeks, the average change in six-minute walking distance from the starting point was an increase of about 10 metres in the six-times-a-day iloprost group, an increase of about 30 metres in the four-times-a-day iloprost group, and a decrease of about 22 metres in the placebo group. For a secondary measure looking at disease severity (rated on a scale from I to IV, where lower is less severe), 4 participants in the six-times-a-day group, 6 in the four-times-a-day group, and none in the placebo group moved to a less severe category by week 16. Regarding clinical worsening (a combined measure including hospitalisation, need for additional treatment, or death related to the condition), the reported data shows 0, 1, and 1 participants experienced this in the three double-blind groups respectively, and 2 and 3 participants in the two open-label groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00946114 · results posted 30 March 2010

  According to the results reported on ClinicalTrials.gov, this trial (NCT00946114) involved 32 people in total. Twenty participants were given a lower dose of sildenafil (60 mg) and twelve were given a higher dose (240 mg). The trial was primarily measuring how many participants experienced adverse events — that is, any unwanted or unexpected medical occurrences while taking the study medication — including serious adverse events, which are defined as those that were life-threatening, required a hospital stay, resulted in death, or caused lasting disability. The reported data shows that in the lower-dose group (60 mg), 11 out of 20 participants experienced an adverse event of any kind, and 8 out of 20 experienced a serious adverse event. In the higher-dose group (240 mg), 8 out of 12 participants experienced an adverse event of any kind, and 2 out of 12 experienced a serious adverse event. No other outcome measures appear to have been reported in the submitted data. It is also worth noting that not everyone completed the trial — 8 people in the lower-dose group and 2 in the higher-dose group did not finish the study, though the reasons for this were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00159913 · results posted 21 July 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 234 children and young people in total, split across four groups: a low dose of sildenafil (42 participants), a medium dose (55 participants), a high dose (77 participants), and a placebo — a dummy treatment containing no active medicine (60 participants). The vast majority of participants finished the study. The trial was primarily measuring how much a person's peak oxygen uptake during exercise changed over 16 weeks. Oxygen uptake during exercise (sometimes called peak VO2) is a way of gauging how well the heart and lungs are working together during physical effort. The reported data shows that, after 16 weeks, the placebo group's peak oxygen uptake had changed by about 0.5% from where it started. By comparison, the low-dose sildenafil group showed a reported change of around 6.4%, the medium-dose group around 13.4%, and the high-dose group around 10.6%. When all sildenafil doses were combined, the reported average change was roughly 10.2%. The trial also measured several other things related to blood pressure and resistance in the lungs' blood vessels. The reported data shows that, for most sildenafil groups, these lung pressure and resistance figures moved in a downward direction from baseline, while the placebo group's figures stayed roughly the same or moved slightly. For one measure of time spent exercising at peak effort, all sildenafil groups showed larger reported percentage increases compared with the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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See the full Pulmonary Hypertension page · What changed recently

Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.