Reported trial results for Heart Disease

Every Heart Disease trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

98 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

NCT04272060 · results posted 16 June 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 175 people in total, all of whom completed the study. Of those, 173 had a complete CT scan. The trial was measuring how accurately two types of heart artery imaging — a newer, high-resolution CT scan (called ultra-high-resolution CT, or UHR-CT) and a traditional invasive procedure where dye is injected directly into the arteries (called invasive coronary angiography, or ICA) — could correctly identify whether patients had a significant narrowing in their heart arteries. A separate pressure-based measurement taken during the invasive procedure (called quantitative flow ratio, or QFR) was used as the benchmark to judge both imaging methods against. The reported data shows that, at the level of individual patients, the CT scan correctly classified 80.3% of participants, while the invasive angiography correctly classified 83.2%. For the secondary outcomes, the reported data shows that the CT scan correctly identified people who did have significant artery narrowing (known as sensitivity) in 86.1% of cases, compared with 89.6% for the invasive angiography. It correctly identified people who did not have significant narrowing (known as specificity) in 69% of cases for the CT scan and 70.7% for the invasive angiography. The two methods agreed with each other on patient classification 80.9% of the time. When looking at individual arteries rather than whole patients, the CT scan's accuracy was reported at 84%, compared with 87.8% for invasive angiography. The reported data also includes exploratory results broken down across several patient subgroups, where CT scan accuracy figures ranged from approximately 78.6% to 82.6% and invasive angiography figures ranged from approximately 81.9% to 89.5%, though these analyses were described as descriptive only and not designed to draw firm 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT06791967 · results posted 12 May 2026

According to the results reported on ClinicalTrials.gov, this trial involved 68 people in total — 34 in a home-based walking group and 34 in a general health education group. The trial was measuring three things in people living with heart failure: depression levels (using a questionnaire called the PHQ-9, scored 0–27, where higher means more severe depression), frailty (using a scale called the CSHA-CFS, scored 1–9, where higher means greater frailty), and quality of life (using a questionnaire called the MLHFQ, scored 0–105, where higher means heart failure is having a bigger negative impact on daily life). Of the 68 who started, 66 completed the trial — one person from each group did not finish. The reported data shows measurements were taken at three time points. For depression scores, the home-based walking group started at 4.62, then moved to 2.21, then 1.33; the general health education group started at 5.21, then moved to 4.73, then 3.58. For frailty scores, the home-based walking group started at 1.97, then 1.70, then 1.52; the general health education group started at 2.24, then 2.06, then 1.85. For quality of life scores, the home-based walking group started at 17.56, then 8.48, then 5.33; the general health education group started at 17.68, then 16.88, then 15.09. It is worth noting that the data as submitted does not label which time points these measurements correspond to, so the exact timing of each reading was not reported in a way that can be confirmed 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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NCT07280208 · results posted 25 February 2026

According to the results reported on ClinicalTrials.gov, this trial involved 57 participants, all of whom were in a single group that received a "teach-back" education session — a method where patients are asked to repeat information back to check their understanding. All 57 participants completed the study. The trial was measuring two things: how participants' scores on a heart failure self-care behaviour questionnaire changed after the education session, and how many participants were admitted back to hospital within 30 days of being discharged. The reported data shows that, on average, participants' scores on the self-care behaviour questionnaire (called the EHFScB-9, a 9-question survey scored from 9 to 45) changed by minus 17.89 points from before the education session to after it. On this particular scale, a lower score means a person is reporting behaviours that more closely match recommended self-care practices, so a drop in score indicates a shift in the direction considered better on the scale. For the second measure, the reported data shows that 1 out of 57 participants was recorded as being readmitted to hospital within 30 days of discharge. Because this trial had only one group and no comparison group, these numbers describe what was observed in this group alone. It is worth noting that this trial did not include a control or comparison group — meaning there is no separate group of participants who did not receive the intervention to compare these numbers against. 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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NCT05093933 · results posted 19 December 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05093933) enrolled 3,053 people in the vericiguat group and 3,052 in the placebo group — just over 6,100 participants in total. The trial was measuring how often people experienced either a heart-failure-related hospitalisation or a death caused by a cardiovascular (heart or blood vessel) problem, whichever came first. It also tracked several related outcomes separately, including deaths from cardiovascular causes, deaths from any cause, and hospital admissions for heart failure. The reported data shows the following figures, expressed as the number of events for every 100 "patient-years" (a way of accounting for the fact that different people were followed for different lengths of time — roughly, how many events occurred per 100 people over one year of follow-up). For the main combined outcome of cardiovascular death or heart failure hospitalisation, the vericiguat group recorded 11.3 events per 100 patient-years compared with 12.2 in the placebo group. For cardiovascular death alone, the figures were 5.7 (vericiguat) versus 6.8 (placebo). For heart failure hospitalisation alone, they were 7.2 versus 7.6, and when all heart failure hospitalisations — including repeat admissions — were counted, the figures were 10.7 versus 11.8. Looking at the broader measures, deaths from any cause combined with heart failure hospitalisations were reported as 12.7 versus 13.9 per 100 patient-years, and deaths from any cause alone were 7.3 versus 8.6. 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 ↗
NCT04986202 · results posted 27 August 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04986202) enrolled 711 participants across three groups: 235 people received a lower dose of AZD4831 (2.5 mg), 240 received a higher dose (5 mg), and 236 received a placebo (a dummy treatment with no active ingredient). The trial was measuring two main things: how participants felt about their heart symptoms using a questionnaire called the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (a 0–100 scale where higher scores mean people felt better), and how far participants could walk in six minutes. These were measured at 16 weeks and again at 24 and 48 weeks. The reported data shows that at 16 weeks, the symptom score had changed from the starting point by around 10.7 points in the 2.5 mg group, 9.8 points in the 5 mg group, and 11.6 points in the placebo group. For the six-minute walk test, distances changed by about 15 metres, 18 metres, and 13 metres respectively for the three groups. At later time points (24 and 48 weeks), the reported symptom score changes were similar across all three groups, ranging from roughly 11 to 13 points, and the walk distance changes ranged from approximately 14 to 19 metres across the groups. The trial also measured a blood marker linked to heart stress called NT-proBNP and a heart ultrasound measure called left ventricular global longitudinal strain (which reflects how well the heart muscle squeezes); the reported changes in these measures across the three groups at all time points were small and close to one another, as shown 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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NCT02280941 · results posted 6 April 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 32 participants, with 31 completing the study and 1 not completing it. The trial involved a type of heart imaging called SPECT (Single Photon Emission Computed Tomography), and it was measuring how well SPECT scans could estimate blood flow through the heart muscle — a measurement known as myocardial blood flow (MBF). Specifically, the trial looked at two things: how closely SPECT's blood flow readings matched those from a more established imaging method called PET (Positron Emission Tomography), and how consistent SPECT's readings were when the same person was scanned twice. The reported data shows that when comparing blood flow measurements between the two scanning methods (SPECT and PET), the average difference in readings was 0.06 units (measured as "mean residual difference in MBF"). For the second part of the trial, participants had two SPECT scans done roughly 18 days apart on average. The reported data shows that the blood flow readings between those two scans differed by an average of 29.5%. This figure reflects how much the measurements varied from one scan to the next in the same person. No other outcome measures were reported in the submitted data beyond these two comparisons. 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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NCT05002088 · results posted 28 February 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 71 people in total — 57 in the main study group (called the "Primary Analysis Population") and 14 in a separate observation group (called the "Exploratory Registry Arm"). The trial was measuring outcomes related to a heart valve procedure, tracking things like deaths from any cause, serious stroke, severe bleeding needing a blood transfusion, kidney injury needing dialysis, and major complications with blood vessels. Of the 57 people in the main group, 7 completed the study, while 50 did not complete it; in the registry group, 4 completed and 10 did not. The data does not explain the reasons for not completing. The reported data shows that for the primary safety measure — a combined count of serious events including death, disabling stroke, life-threatening bleeding, kidney injury requiring dialysis, and major vascular complications — 2 participants in the main group and 0 in the registry group met that combined endpoint. For the primary performance measure — death from any cause or disabling stroke combined — 7 participants in the main group and 0 in the registry group were recorded. On a secondary measure of procedural success (defined as no death during the procedure and the device being successfully delivered and retrieved), 53 out of 57 people in the main group and 12 out of 14 in the registry group met that definition. Various other adverse events (unwanted medical occurrences) were also tracked and reported as percentages across different follow-up time points, with figures in the main group ranging from 0% to approximately 12.4% depending on the specific event and time point measured; the registry arm figures ranged from 0% to approximately 15.6%. 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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NCT02954341 · results posted 24 February 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT02954341) enrolled 321 people who had agreed to take part. Of these, 304 received the implanted wireless pressure sensor (called the "safety population"), and 299 had it successfully implanted (called the "effectiveness population"). The trial was measuring three main things: whether participants were free from serious complications related to the device or system; whether the pressure sensor continued to work without failing; and whether the rate of hospital admissions for heart failure changed over the year after the device was implanted compared to the year before. The reported data shows that all 304 people in the safety group were recorded as free from device or system-related complications — meaning no one in that group experienced a complication defined as requiring an invasive procedure, resulting in death, or requiring the device to be removed. For sensor reliability, 298 out of 299 people in the effectiveness group were reported as free from sensor failure, meaning the sensor kept producing readings for nearly all participants. Regarding hospital admissions for heart failure, the reported data shows three figures: 1.59, 0.49, and 0.31 admissions per person per year. Based on the way the outcome was described, these appear to represent the rate before enrolment and rates at different follow-up points afterward, however the data as submitted does not clearly label which figure corresponds to which time point, so a precise breakdown cannot be stated here. It is worth noting that 131 of the 321 people who started did not complete the study, and 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04509674 · results posted 7 January 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04509674) enrolled 6,522 people in total — 3,262 in the placebo group and 3,260 in the empagliflozin 10 mg group. The trial was measuring outcomes related to heart failure and death, primarily looking at how often participants were first hospitalised for heart failure or died from any cause. A range of secondary outcomes were also tracked, including total numbers of heart-related hospital admissions and deaths from various causes over time. The reported data shows that for the main (primary) outcome — the rate of first hospitalisation for heart failure or death from any cause — the placebo group had a rate of 6.58 events per 100 patient-years (meaning per 100 people followed for one year), while the empagliflozin group had a rate of 5.85 events per 100 patient-years. For the secondary outcomes, the reported adjusted rates per 100 patient-years were: total heart failure hospitalisations or any-cause death — 8.25 (placebo) versus 7.14 (empagliflozin); total unplanned heart-related hospitalisations or any-cause death — 16.90 versus 15.52; total unplanned hospitalisations from any cause or any-cause death — 26.28 versus 22.96; and total heart attack hospitalisations or any-cause death — 6.27 versus 6.66. The reported rate of death specifically from a cardiovascular (heart or blood vessel) cause was 2.76 per 100 patient-years in the placebo group and 2.78 in the empagliflozin 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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NCT02777580 · results posted 4 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT02777580) enrolled 609 people who had suffered a heart attack. Participants were split into two groups: 405 people received a "pharmaco-invasive" approach (where clot-dissolving medication was given first, followed by a procedure to open the blocked artery) and 204 people received standard emergency angioplasty (a procedure to open the blocked artery directly, without prior medication). The trial was measuring several things: how well blood flow was restored to the heart, and how many people experienced serious events — such as death from any cause, heart failure, shock, or another heart attack — within 30 days. It also tracked strokes and major bleeding episodes. The reported data shows the following numbers for each group. On the measure of successful restoration of blood flow to the heart, 305 out of 405 participants in the pharmaco-invasive group and 149 out of 204 in the standard angioplasty group met this measure. For the combined count of serious events (death, shock, heart failure, or repeat heart attack within 30 days), 51 participants in the pharmaco-invasive group and 27 in the standard angioplasty group experienced at least one of these events. Regarding stroke, 9 participants in the pharmaco-invasive group and 1 in the standard angioplasty group had a stroke recorded. For major bleeding not involving the brain, 5 participants in the pharmaco-invasive group and 2 in the standard angioplasty group were reported to have experienced this. 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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NCT02884206 · results posted 6 August 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 706 people to begin with. Participants first went through two lead-in (run-in) periods — one taking valsartan and one taking LCZ696 — to check suitability before the main part of the study. After those run-in stages, 592 people moved into the main double-blind phase, where 295 were randomly assigned to LCZ696 (200 mg twice daily) and 297 to valsartan (160 mg twice daily). The trial was measuring whether LCZ696 had a different effect compared to valsartan on thinking and memory abilities over three years, as well as on a brain-scan measure of a protein called amyloid (which can accumulate in the brain) and on people's ability to carry out everyday tasks. The reported data shows that the main (primary) measure was a combined thinking-and-memory score called the Global Cognitive Composite Score — a higher number meaning better performance. Both groups showed a small decline from their starting scores over the study period: the LCZ696 group had a reported change of −0.090 and the valsartan group −0.072 (on a standardised scale where scores are relative to a reference group). For the brain-scan substudy, which looked at amyloid deposits across several brain regions, the reported data shows that both groups had increases in amyloid levels from their starting point, with the valsartan group generally showing slightly larger increases across most regions measured. For the three individual thinking areas tested (memory, executive function, and attention), the reported changes were all small and close to zero for both groups. The reported data also shows that on the everyday activities questionnaire (scored 0–30, where lower is better), both groups had small increases from their starting point — LCZ696 approximately +0.60 and valsartan approximately +0.71. 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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NCT02325830 · results posted 5 August 2024

According to the results reported on ClinicalTrials.gov, this trial (called REDUCE FMR) enrolled 120 people in total — 87 in the treatment group (who received a small implanted device called the Carillon) and 33 in the control group (who did not). Of those, 70 people in the treatment group and 24 in the control group completed the study. The trial was measuring changes in a heart condition called functional mitral regurgitation — where a heart valve leaks blood backwards — by looking at the volume of blood leaking with each heartbeat, as well as other measures of heart function and physical ability over 12 months. The reported data shows that, on average, the amount of blood leaking backwards per heartbeat (called regurgitant volume, measured in millilitres) changed by minus 7.07 ml in the treatment group, meaning it went down on average, while in the control group it went up by an average of 3.32 ml. For hospitalisations due to worsening heart failure, the reported rate was 0.57 episodes per person per year in the treatment group compared with 0.73 in the control group. When participants were asked to walk as far as they could in six minutes, the treatment group's distance increased by an average of 32 metres from their starting point, while the control group's increased by an average of 17.5 metres. The reported data also shows changes in the size of the heart's main pumping chamber, with the treatment group showing reductions in volume and the control group showing increases, though the specific figures for each measurement (systole and diastole) were listed separately in the data. It is worth noting that the data entry for the second primary outcome (major adverse events) appears to have been recorded with the same regurgitant volume numbers rather than a separate count of events, so a meaningful breakdown of adverse event rates was not clearly 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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NCT03037931 · results posted 3 July 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03037931) enrolled 3,065 people in total — 1,532 in the ferric carboxymaltose (an iron treatment given by infusion) group and 1,533 in the placebo group. The trial was measuring three things: how many participants died, how many were admitted to hospital for heart failure, and how far participants could walk in six minutes (a common way of measuring physical capacity in heart failure trials) at the start of the trial compared to six months later. The reported data shows that in the ferric carboxymaltose group, 131 participants died and 297 were hospitalised for heart failure. In the placebo group, 158 participants died and 332 were hospitalised for heart failure. For the six-minute walk test, the reported data shows that participants in the ferric carboxymaltose group walked an average of about 8 metres more at six months compared to their starting point, while those in the placebo group walked an average of about 4 metres more compared to their starting point. These are the raw numbers as submitted; the trial's own statistical analysis of what those differences mean was not included in the data provided here. It is also worth noting that not everyone who started the trial completed it — around 409 people in the ferric carboxymaltose group and 412 in the placebo group did not finish, 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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NCT03237858 · results posted 27 March 2024

According to the results reported on ClinicalTrials.gov, this trial — called MANAGE-HF Phase I — enrolled 200 people with heart failure. The study used a device called HeartLogic, which monitors patients remotely, and the goal of this phase was to test how well the device and its alert system could be built into everyday clinical care. All 200 participants were in a single group, meaning there was no comparison group. Of those who started, 144 people completed the study and 56 did not finish. The reported data shows that Phase I was described by the researchers as having no formal outcome measures. In other words, this phase of the trial was not set up to measure whether the device produced a particular health result — it was focused on evaluating and fine-tuning how the alert management system worked in practice. The one figure reported under the primary outcome category shows 191 participants, though the trial record does not provide further explanation for why this number differs slightly from the 200 who started or the 144 who completed the study. No additional secondary outcome data was reported. Because this phase had no defined outcome measures, there are no results figures — such as changes in health scores or event rates — to describe. The reported data simply documents the process of setting up and refining the system rather than testing its effect on participants' health. 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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NCT04668144 · results posted 20 March 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04668144) enrolled 77 people in total, split across three groups: one group received prasugrel alone (25 people), one received prasugrel and cangrelor together (25 people), and one received cangrelor followed by prasugrel (27 people). The trial was measuring platelet reactivity — in simple terms, how "sticky" the blood platelets were — using a device called VerifyNow, which gives a score in units called PRU (P2Y12 Reaction Units). A higher PRU score generally means platelets are more active. Nearly all participants completed the study, with one person not finishing in the prasugrel-plus-cangrelor group and two not finishing in the cangrelor-followed-by-prasugrel group. The reported data shows the average PRU scores at the time of measurement for each group. The prasugrel-only group recorded a score of 23 PRU, the prasugrel-plus-cangrelor group recorded a score of 153 PRU, and the cangrelor-followed-by-prasugrel group recorded a score of 65 PRU. These numbers reflect what was measured and reported for each group; no additional outcome measures or safety data were included in the results submitted to ClinicalTrials.gov, so further detail beyond these figures was 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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NCT04282148 · results posted 12 February 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04282148) enrolled 105 participants, all of whom received a drug-eluting stent (a small mesh tube placed in a blocked artery to help keep it open, coated with medication). Of the 105 people who started the trial, 96 completed it and 9 did not. The trial was mainly measuring a combined event called "Target Lesion Failure" (TLF) — this means tracking whether participants experienced any of three things: death from a heart-related cause, a heart attack connected to the treated artery, or a procedure to re-open the same artery because it had narrowed again. The reported data shows that the primary result — calculated using a statistical method called a Kaplan-Meier estimate (a way of tracking how many people experienced an event over time, accounting for those who left the study early) — put the rate of Target Lesion Failure at one year at 5.7%. The secondary outcome measures also tracked TLF at various time points across the follow-up period. The reported numbers of participants who experienced TLF at these different time points ranged from 4 to 10 participants depending on the time point and the specific component being counted (cardiac death, heart attack connected to the treated vessel, or repeat procedure). The data as submitted does not include clear labels for each individual time point, so a precise breakdown by time point 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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NCT03917459 · results posted 8 January 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03917459) enrolled 27 men with chronic heart failure — 13 in the LCZ696 group and 14 in the Enalapril group. Both are medicines used in heart failure. The trial was measuring erectile function, self-reported frequency of sexual activity, and levels of a heart-related protein in the blood called NT-proBNP (a marker that can reflect how hard the heart is working). Most participants finished the study: 12 in the LCZ696 group and 13 in the Enalapril group. The reported data shows that erectile function was measured using a 15-question self-reported questionnaire called the IIEF-15, where scores on the erectile function section can range from 1 to 30, with higher scores indicating better reported function. At the end of the study, the LCZ696 group reported an average score of 15.1, while the Enalapril group reported an average score of 12.2. For self-reported sexual activity per week, the reported data shows changes from the starting point at two separate time points — both groups reported reductions in frequency across both time points, ranging from –1.1 to –2.0 activities per week. For the NT-proBNP blood marker, the reported data shows reductions from baseline in both groups at both time points measured (Week 4 and Week 12), with figures ranging from –43.50 to –369.00 pg/mL across the groups and time points. It is worth noting that this was a small trial with fewer than 30 participants in total, which limits how broadly any numbers can be interpreted. The reported data shows only the figures submitted by the study sponsor; no conclusions about whether one treatment performed better than another should be drawn from this summary 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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NCT01341964 · results posted 27 July 2023

According to the results reported on ClinicalTrials.gov, this trial involved 302 people split into two groups — 152 people in a higher-dose aspirin group and 150 people in a low-dose aspirin group. All participants completed the study, with no drop-outs recorded. The trial was measuring the blood concentration of the active form of a medicine called clopidogrel (a blood-thinning tablet) in people taking different doses of aspirin alongside it. The idea was to see whether the dose of aspirin made a difference to how much of the active form of clopidogrel appeared in the bloodstream. The reported data shows that the average blood concentration of the active form of clopidogrel was 14.45 ng/ml (nanograms per millilitre — a very small unit used to measure tiny amounts of a substance in the blood) in the higher-dose aspirin group, and 13.80 ng/ml in the low-dose aspirin group. These were the only outcome figures submitted to ClinicalTrials.gov for this trial; no secondary outcome measure data was reported in the structured 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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NCT04767061 · results posted 3 July 2023

According to the results reported on ClinicalTrials.gov, this was a small clinical trial involving 9 people in total — 5 in one group and 4 in another. All 9 participants completed the trial. The study used what is called an "N-of-1" design, meaning each person took turns being on their usual dose of beta-blocker medication and then on a very low (minimally tolerated) dose, so each participant acted as their own comparison. The trial was measuring whether being on or off beta-blockers made a difference to things like daily step count, physical function, exercise capacity, and self-reported quality of life. The reported data shows the following average figures when participants were on beta-blockers compared to when they were off them. For daily steps recorded by a wearable device, the average was about 2,791 steps per day while on beta-blockers and about 3,167 steps per day while off them. For balance (scored 0–4, where higher is better), the average score was 3.9 while on beta-blockers and 3.6 while off. For walking speed across 4 metres, it took an average of 4.3 seconds while on beta-blockers and 4.6 seconds while off (a shorter time means faster walking). For the chair-rise test (time to stand up from a chair 5 times), the average was 16 seconds while on beta-blockers and 15.1 seconds while off. For peak oxygen consumption during an exercise test — a measure of how hard the body can work — the average was 10.0 ml/kg/min while on beta-blockers and 11.4 ml/kg/min while off. The reported data also shows a secondary measure of self-reported quality of life using a standardised questionnaire (scored against a general population average of 50, where lower scores indicate worse health compared to that average). Two sets of scores appear to have been recorded across different time points: one set showed averages of approximately 39.8 (on beta-blockers) and 40.0 (off beta-blockers), and another set showed averages of approximately 46.8 (on beta-blockers) and 47.9 (off beta-blockers); further detail about what these two time points represent was 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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NCT04327024 · results posted 29 June 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04327024) enrolled 159 people across three groups — 53 received a combination of verinurad and allopurinol, 53 received allopurinol alone, and 53 received a placebo (an inactive treatment). The trial was primarily measuring changes in "peak VO2" — a standard test of how much oxygen the body can use during exercise, which gives an indication of heart and lung fitness — after 32 weeks. The trial also measured changes in a heart failure symptom questionnaire called the KCCQ (Kansas City Cardiomyopathy Questionnaire), where higher scores mean a person feels their symptoms are better. The reported data shows that for the main (primary) outcome — the change in peak VO2 from the start of the trial to week 32 — the verinurad plus allopurinol group showed an average change of +0.27 mL/kg/min, while the placebo group showed an average change of +0.37 mL/kg/min. According to the results reported on ClinicalTrials.gov, this difference did not reach the threshold set by the researchers to be considered a meaningful finding, and as a result, the pre-planned testing sequence for the secondary outcomes did not formally continue. For the secondary outcome comparing verinurad plus allopurinol to allopurinol alone, the combination group showed a change of +0.27 mL/kg/min versus −0.17 mL/kg/min for allopurinol alone. For the symptom questionnaire (KCCQ), the reported data shows changes across groups were modest and varied between timepoints, with no single group showing a clearly large shift in scores compared to another. 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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NCT02924727 · results posted 22 June 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02924727) enrolled 2,834 people in the LCZ696 (sacubitril/valsartan) group and 2,835 people in the ramipril group — nearly 5,700 participants in total. The trial was comparing the two medicines in people with heart failure, and it was measuring how many participants experienced certain serious heart-related events, including death from a heart-related cause, being admitted to hospital for heart failure, or needing an unplanned outpatient visit for heart failure. The reported data shows that for the main (primary) outcome — which combined heart-related death, heart failure hospitalisation, and unplanned outpatient heart failure visits —338 participants in the LCZ696 group and 373 participants in the ramipril group experienced at least one of these events. For the secondary outcomes, the reported numbers were: heart-related death or heart failure hospitalisation occurred in 308 (LCZ696) versus 335 (ramipril) participants; heart failure hospitalisation or unplanned outpatient heart failure visit occurred in 201 versus 237 participants; heart-related death, non-fatal heart attack, or non-fatal stroke occurred in 315 versus 349 participants; and deaths from any cause were recorded in 213 versus 242 participants. The total count of all combined serious events across the trial was reported as 416 events in the LCZ696 group and 455 events in the ramipril group. These figures are counts of how many people experienced each event during the trial period, and no further detail about the reasons for any differences between groups was included in the structured 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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NCT03775421 · results posted 7 March 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03775421) enrolled 111 participants, all of whom received a 10 mg daily dose of a medicine called macitentan. Only 1 participant was recorded as completing the study, while 110 did not complete it — though the data does not explain the reasons for this in detail. The trial was primarily focused on monitoring and recording medical events (called adverse events) that occurred during treatment, as well as tracking certain blood test results over time. There was no comparison group; everyone received the same treatment. The reported data shows that out of the 111 participants, 68 experienced at least one treatment-emergent adverse event — meaning an unwanted medical occurrence that happened during or shortly after the treatment period. Of those, 18 experienced a serious adverse event (one serious enough to cause hospitalisation, be life-threatening, or have another significant impact). The reported data shows that 1 participant died during the study period, and 2 participants stopped taking the study treatment early due to an adverse event. Separately, a small number of participants showed notable changes in specific blood test results — for example, 10 participants had an unusual result for a measure called lymphocytes (a type of white blood cell), and smaller numbers had unusual results across other blood markers. The trial also tracked changes in haemoglobin (a measure of red blood cell health) over time, with the reported data showing small average decreases at most time points, ranging from around −6.0 to −2.4 g/L, and one time point showing an average increase of 5.7 g/L. 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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NCT04394754 · results posted 23 December 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT04394754) enrolled 182 people with heart failure across four groups: a Control group (44 people), and three groups using different digital health tools — BodyPort (46 people), Noom (46 people), and Conversa (46 people). The trial ran for 180 days and was primarily measuring changes in how participants rated their own quality of life, using a standard heart failure questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ). On this questionnaire, higher scores (up to 100) reflect better self-reported health, and lower scores reflect worse. The trial also tracked hospital admissions over the same period. By the end of the study, roughly 7–8 people in each group did not complete the trial. The reported data shows that for the primary outcome — change in quality of life scores at 90 days — the shifts from starting scores were generally small across all groups. The reported median changes at 90 days ranged from −4.2 points (Control, BodyPort, and Conversa groups) to 0 points (Noom group), meaning most groups' median scores stayed the same or dipped slightly on the questionnaire scale. For the secondary quality-of-life measure at 180 days, the reported median changes ranged from −8.3 points (BodyPort) to 0 points (Control and Conversa), with the Noom group showing a small positive shift of +6.3 points in one sub-score. Regarding hospital admissions, the reported data shows that between enrolment and 90 days, the number of participants admitted to hospital was 11 in the Control group, 16 in BodyPort, 14 in Noom, and 17 in Conversa. Between 90 and 180 days, admissions were reported as 10 (Control), 15 (BodyPort), 15 (Noom), and 14 (Conversa). For the outcome measuring changes in prescribed heart medications, no numerical data was reported on 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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NCT02525939 · results posted 12 October 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT02525939) enrolled 6,147 people in total — 3,071 in the dalcetrapib group and 3,076 in the placebo group (a placebo is a dummy treatment with no active ingredient). The trial was measuring whether dalcetrapib, compared to placebo, was associated with fewer serious heart-related events in people who had recently experienced a heart attack. The main thing researchers tracked was how long it took for a participant to have their first serious cardiovascular event, such as dying from a heart-related cause, having a non-fatal heart attack, having a non-fatal stroke, or needing resuscitation after cardiac arrest. The reported data shows that for the primary (main) outcome — the number of participants who experienced at least one of those serious heart-related events — 292 people in the dalcetrapib group and 327 people in the placebo group reached that milestone. For the first secondary outcome, which added hospitalisations for a type of chest pain emergency or unplanned heart procedures to the list of events, the reported data shows 471 participants in each group experienced at least one such event. For the second secondary outcome, which added hospitalisations for new or worsening heart failure, the reported data shows 321 people in the dalcetrapib group and 346 people in the placebo group experienced at least one event. The reported data shows these are the raw counts of participants who experienced each category of event; no further detail — such as timing or statistical comparisons — was available in the data submitted to ClinicalTrials.gov for this summary. 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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NCT01125436 · results posted 10 August 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 64 people in total — 31 in a group receiving cholecalciferol (a form of vitamin D) plus calcium, and 33 in a group receiving a placebo (dummy treatment) plus calcium. The trial was measuring things like heart and lung fitness, leg muscle strength, and physical mobility in these participants. Of those who started, 19 people in the vitamin D group and 21 in the placebo group completed the study, with 12 people in each group not finishing. The reported data shows the following changes over the course of the trial. For the main measure — peak aerobic capacity (how hard the heart and lungs can work during exercise, measured in millilitres of oxygen per kilogram of body weight per minute) — both groups showed a small decline: minus 0.17 in the vitamin D plus calcium group and minus 0.68 in the placebo plus calcium group. For the six-minute walk test (how far someone can walk in six minutes), the reported data shows an increase of 59 metres in the vitamin D group and 36 metres in the placebo group. For leg muscle strength, the data reports figures of 1.6 and 5.2 newton-metres per kilogram for the vitamin D group, and 5.1 and 3.5 for the placebo group, though the trial record does not make fully clear which specific muscle movements each pair of numbers refers to. The timed "get up and go" test (standing from a chair, walking 3 metres, and returning) showed changes of minus 0.2 seconds in the vitamin D group and minus 1.0 seconds in the placebo group, where a negative number means the task was completed more quickly. The reported data also shows changes in two blood measures. Serum aldosterone (a hormone involved in blood pressure regulation) changed by plus 3.7 ng/dl in the vitamin D group and minus 0.1 ng/dl in the placebo group. Plasma renin activity (another marker related to blood pressure) changed by plus 1.3 ng/ml/hr in the vitamin D group and minus 2.5 ng/ml/hr 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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NCT03276728 · results posted 8 August 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03276728) tested a drug called AMG 986 against a placebo (an inactive dummy treatment) across three parts — Part A, Part B, and Part C. In total, 182 people started the trial. Part C focused specifically on people living with heart failure, split into two types: heart failure with reduced pumping ability (HFrEF) and heart failure with preserved pumping ability (HFpEF). The trial was primarily measuring how many participants experienced unexpected medical events (called adverse events) after taking the study drug or placebo, and also tracked heart measurements such as how well the heart's main pumping chamber was working. The reported data shows that in terms of adverse events — that is, any unwanted medical occurrence during the study — across the different groups, the numbers who experienced these events were: 3 out of 22 in the Part A placebo group, 11 out of 66 in the Part A AMG 986 group, 2 out of 16 in the Part B placebo group, 7 out of 50 in the Part B AMG 986 group, 2 out of 7 in the Part C HFrEF placebo group, 1 out of 1 in the Part C HFpEF placebo group, 6 out of 16 in the Part C HFrEF AMG 986 group, and 3 out of 3 in the Part C HFpEF AMG 986 group. The reported data also shows that no serious adverse events (those involving hospitalisation, life-threatening situations, or similar severe outcomes) were recorded in any group. For the heart failure measurements in Part C's HFrEF group, the reported data shows that ejection fraction — a percentage reflecting how much blood the heart pumps out with each beat — ranged roughly between 28% and 35% across different time points in both the placebo and AMG 986 groups. The amount of blood pumped per heartbeat (stroke volume) was also tracked, with figures generally ranging from around 40 to 59 millilitres across time points and measurement methods in both 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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NCT04336995 · results posted 12 July 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants, all of whom completed the study — none dropped out. The trial involved an exercise-based intervention and was measuring something called **pulmonary transit time**, which is the number of seconds it takes for blood to travel through the blood vessels in the lungs. The reported data shows that the measured pulmonary transit time for the exercise group was **2.5 seconds**. It is worth noting that only this single primary outcome figure was reported in the submitted results. No secondary outcome measures or comparison data (such as a control or non-exercise group) appear to have been reported on ClinicalTrials.gov, so no further 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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NCT03057951 · results posted 6 June 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03057951) enrolled just under 6,000 adults — approximately 2,991 in the placebo group and 2,997 in the empagliflozin (10 mg) group. The trial was measuring whether empagliflozin, compared to a placebo (inactive pill), was associated with differences in rates of serious heart-related events in people with heart failure with preserved pumping function. The main thing researchers tracked was how often participants experienced either a cardiovascular-related death or a hospital admission for heart failure, whichever came first. Several other outcomes were also tracked, including kidney function over time. The reported data shows that for the primary outcome — the combined rate of cardiovascular death or first hospitalisation for heart failure — the placebo group recorded 8.67 such events per 100 patient-years (a way of counting events that accounts for how long people were followed), while the empagliflozin group recorded 6.86 events per 100 patient-years. For cardiovascular death alone, the reported rates were 3.81 (placebo) and 3.42 (empagliflozin) per 100 patient-years. For first hospitalisation for heart failure alone, the figures were 5.97 (placebo) and 4.28 (empagliflozin) per 100 patient-years. When counting all hospitalisations for heart failure — including repeat admissions — the reported totals were 541 in the placebo group and 407 in the empagliflozin group. For kidney function, the reported data shows that kidney filtration capacity (a measure of how well the kidneys filter blood) declined at a rate of approximately 2.62 units per year in the placebo group and 1.25 units per year in the empagliflozin group. The rate of serious kidney events (such as needing dialysis or a significant sustained drop in kidney function) was 2.23 per 100 patient-years for placebo and 2.13 for empagliflozin. 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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NCT02230254 · results posted 12 May 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 101 people who were treated with a coronary stent called the PROMUS PREMIER Stent. The trial was measuring how well the stent could be delivered and positioned in a blocked heart artery — specifically whether it could be placed successfully without complications during the procedure, and whether the artery remained sufficiently open immediately afterwards. Of the 101 participants who started, 98 completed the study and 3 did not. The reported data shows that the main outcome — called "technical success" — was achieved in 99.1% of participants. In plain terms, this means that in nearly all cases, the stent was reported to have been delivered to the right spot, deployed without the balloon bursting or the stent moving out of place, and the artery was left with good blood flow and less than 30% narrowing remaining, as judged by the treating doctor at the time of the procedure. The reported data shows that several other outcomes were also intended to be measured, including rates of repeat procedures on the treated artery, heart attacks, and broader problems with the treated blood vessel. However, no numerical results for any of these secondary outcomes were included in the data submitted to ClinicalTrials.gov, 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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NCT02100722 · results posted 20 January 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT02100722) enrolled 1,500 people in total — 757 in a group that received a procedure called FFR-guided PCI (a way of opening blocked heart arteries using a wire-guided stent) and 743 in a group that had open-heart bypass surgery (CABG). The trial was measuring serious heart-related events over time, including death, heart attack, stroke, and the need for any further procedure to open blocked arteries. The reported data shows that for the main (primary) outcome — tracking how many people experienced any of those serious events within one year — 80 out of 757 participants in the FFR-guided PCI group and 51 out of 743 participants in the bypass surgery group reached that combined endpoint. For a key secondary outcome looking at death, heart attack, or stroke together over three years, the reported numbers were 91 participants in the PCI group and 68 in the bypass surgery group. The reported data also shows that when looking at death, heart attack, or stroke combined at an earlier follow-up point, 55 participants in the PCI group and 39 in the bypass surgery group experienced those events. For individual events, the reported figures for heart attacks were 39 (PCI) versus 26 (bypass surgery) at one timepoint, with additional breakdowns also reported; for stroke, the numbers were 7 (PCI) versus 8 (bypass surgery); and for deaths, 12 (PCI) versus 7 (bypass surgery) at one reported timepoint, with a separate breakdown of 6 versus 4 also listed. Some of the secondary outcome breakdowns did not include enough detail in the submitted data to clarify exactly which time points each figure refers to, so those specific timepoints are not 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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NCT03570697 · results posted 24 November 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03570697) enrolled 164 people in total — 82 assigned to receive a placebo (an inactive treatment) and 82 assigned to receive a medicine called evolocumab. The trial was measuring changes in the physical characteristics of fatty plaques inside coronary arteries (the blood vessels that supply the heart). Specifically, it looked at something called fibrous cap thickness (FCT) — a thin layer of tissue covering a fatty plaque — and the size of the fatty area within the plaque, both measured using a specialised imaging technique called OCT (optical coherence tomography). A thicker fibrous cap and a smaller fatty area are generally considered more favourable features of a plaque. The reported data shows that, for the main (primary) outcome — the change in the thinnest point of the fibrous cap — the placebo group showed an average increase of 21.5 micrometres (a micrometre is one-thousandth of a millimetre), while the evolocumab group showed an average increase of 42.7 micrometres. For the secondary outcomes, the reported data shows the placebo group had a percentage increase in minimum fibrous cap thickness of around 44%, compared with around 82% in the evolocumab group. The average fibrous cap thickness across all images increased by approximately 29.8 micrometres in the placebo group and 62.3 micrometres in the evolocumab group. Regarding the size of the fatty area within the plaque, the placebo group showed an average reduction of 31.4 degrees and the evolocumab group showed an average reduction of 57.5 degrees. Similar patterns were reported when looking only at plaques that were classed as "lipid rich" (those with a particularly thin cap and large fatty area). 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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NCT02929329 · results posted 20 July 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02929329) enrolled 8,232 people with heart failure — 4,112 in the placebo group and 4,120 in the omecamtiv mecarbil group. The trial was measuring whether omecamtiv mecarbil (a medication being investigated for heart failure) made a difference to how long it took before participants experienced a serious heart failure event — such as a hospital stay, an urgent clinic visit, or an emergency department visit for worsening heart failure — or died from a cardiovascular (heart or blood vessel) cause. Participants' symptoms and quality of life were also tracked using a questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ), which rates symptoms on a scale from 0 (most severe) to 100 (no symptoms). The reported data shows that for the main outcome — a serious heart failure event or cardiovascular death — 37.0% of people in the omecamtiv mecarbil group experienced one of these events, compared with 39.1% in the placebo group. For cardiovascular death alone, 19.6% of the omecamtiv mecarbil group and 19.4% of the placebo group experienced this outcome. For death from any cause, the reported figure was 25.9% in both groups. Regarding heart failure hospitalisation specifically, 27.7% of the omecamtiv mecarbil group and 28.7% of the placebo group were hospitalised. On the symptom questionnaire at 24 weeks, outpatients in both groups showed a modest improvement from their starting scores (omecamtiv mecarbil: +5.83 points; placebo: +6.29 points), while inpatients showed larger improvements in both groups (omecamtiv mecarbil: +23.65 points; placebo: +21.15 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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NCT01562041 · results posted 18 June 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants, all of whom completed the study. There was only one treatment group: people who received ranolazine 500 mg (brand name Ranexa®). The trial was measuring changes in heart-related electrical signals recorded during treadmill exercise tests — specifically, patterns on an ECG (a heart tracing) that can indicate reduced blood flow to the heart during physical activity. Participants completed several treadmill tests before starting the medication and then one test after taking it, so that before-and-after comparisons could be made. The reported data shows the following changes between the pre-treatment average and the post-treatment test. For the three main (primary) measures: the ST/HR index — a measure of how much the ECG signal shifts relative to heart rate during exercise — changed by −0.605 units (microvolts per beat per minute), meaning it was slightly lower after treatment; the ST/HR slope — another way of tracking the same ECG-to-heart-rate relationship — changed by −1.553 units; and the X-axis intercept of the ST/HR slope — roughly, the heart rate at which the ECG signal begins to shift — changed by +2.173 beats per minute. For the secondary measures, total exercise duration on the treadmill changed by +0.755 minutes; the time until a specific ECG change appeared (used as a marker of reduced blood flow) changed by +0.876 minutes; and the time until participants reported chest pain during exercise changed by +0.473 minutes. 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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NCT01786512 · results posted 17 May 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT01786512) enrolled 738 participants across two main phases. The first phase — called the dose-escalation phase — involved smaller groups of people who received either a placebo (a dummy treatment with no active ingredient) or one of two doses of a drug called omecamtiv mecarbil (25 mg or 50 mg), given in different tablet formulations. The second, larger phase — called the expansion phase — involved around 448 people split across a placebo group, a fixed 25 mg dose group, and a group whose dose was adjusted based on how their body processed the drug. The trial was primarily measuring how the drug moved through the body — specifically, how much of it appeared in the bloodstream and how quickly. The reported data shows that in the dose-escalation phase, the highest level of the drug recorded in the blood after the final dose on Day 7 ranged from approximately 171 to 201 ng/mL (nanograms per millilitre, a measure of concentration) for the 25 mg groups, and from approximately 492 to 601 ng/mL for the 50 mg groups. The time it took to reach that peak level ranged from about 2 to 4.6 hours depending on the formulation. In the expansion phase, the reported data shows that peak blood concentrations were around 200–212 ng/mL in the fixed 25 mg group, and around 212–318 ng/mL in the group whose dose was adjusted over time. Some additional measurements across multiple time points were also reported for pre-dose blood levels, though not all time-point labels were 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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NCT01951625 · results posted 25 March 2021

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called BAY1021189 (tested at several different doses) compared to a placebo (a dummy treatment with no active ingredient) in people with heart failure. A total of 456 participants were enrolled across five groups — 92 in the placebo group and 91 in each of the four BAY1021189 dose groups. The trial ran for 12 weeks and measured several things related to heart function, including a blood protein called NTproBNP (a marker that can indicate how much strain the heart is under), heart size and pumping ability measured by ultrasound scans, blood pressure, heart rate, and hospital admissions or deaths related to heart problems. The reported data shows that for the main measure — the change in NTproBNP levels over 12 weeks — all groups, including the placebo group, showed a reduction from their starting levels. The placebo group's average change was −0.28 (on a mathematical scale used to handle the wide range of values), while BAY1021189 groups ranged from −0.265 (lowest dose) to −0.529 (the group whose dose was increased up to 10 mg). For heart size measurements, all groups showed some reduction in the volume of blood the heart holds. The pumping function of the heart (called ejection fraction — the percentage of blood the heart pumps out with each beat) increased slightly in all groups, ranging from about 1.5 percentage points in the placebo group to about 3.7 percentage points in the highest dose group. Blood pressure and heart rate showed small reductions across all groups. Regarding serious clinical events, the reported data shows that 21 placebo participants experienced a heart failure hospitalisation, compared to between 9 and 20 participants across the BAY1021189 dose groups; deaths from heart-related causes were recorded as 6 in the placebo group and between 2 and 5 across the BAY1021189 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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NCT02290028 · results posted 24 March 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02290028) enrolled 2,226 participants, all of whom received a heart device lead called the Sentus QP Left Ventricular Lead — a wire used as part of a cardiac resynchronisation (heart rhythm) device. The trial was measuring things like how often complications related to the lead occurred, and whether the lead was able to deliver electrical pulses at an acceptable level. Notably, the results data shows that zero participants were recorded as having "completed" the study, and all 2,226 were listed as "not completed," though outcome results were still reported. The reported data shows that for the three main (primary) measures: 97.1% of participants were free from lead-related complications at six months after the device was implanted; 93.4% of participants had what the researchers considered an acceptable pacing threshold (meaning the lead required a low enough level of electrical energy to activate the heart) at three months; and 98.03% were free from lead-related complications through to the end of the study. For the additional (secondary) measures, the reported data shows that out of those tested at three months, 226 participants with the "QP L" lead model and 32 with the "QP S" lead model had acceptable pacing thresholds in their main programmed setting. Additionally, 261 participants had at least one acceptable pacing threshold in an alternative setting, and 223 (QP L model) and 32 (QP S model) participants had acceptable electrical signal readings from the heart. Total participant counts for some of these secondary measures were not reported in the submitted data, so the full picture cannot be determined. 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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NCT02108262 · results posted 15 March 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02108262) enrolled a total of 1,267 participants across four groups: a small safety lead-in group of 9 people receiving a 2 g dose of CSL112, followed by three main groups — 419 people receiving CSL112 at 2 g, 421 receiving CSL112 at 6 g, and 418 receiving a placebo (an inactive infusion). The trial was primarily measuring two things: whether CSL112 caused meaningful changes in liver health (using a liver enzyme called ALT and a substance called bilirubin as markers), and whether it caused meaningful changes in kidney health (using a substance in the blood called creatinine as a marker). A secondary focus was whether there were differences between groups in the rate of serious heart-related events, such as heart attack, stroke, cardiovascular death, or hospitalisation for chest pain. The reported data shows that, for the liver health measure, 1.0% of participants in the 2 g CSL112 group and 0.5% in the 6 g group had a clinically meaningful change in liver markers, compared with 0% in the placebo group. For the kidney health measure, 0% of the 2 g CSL112 group and 0.7% of the 6 g group had a clinically meaningful change in kidney markers, compared with 0.2% in the placebo group. For the secondary heart-related events outcome, the reported data shows that 6.4% of the 2 g CSL112 group, 5.7% of the 6 g group, and 5.5% of the placebo group experienced one of these events. The trial also measured blood levels of two substances found in CSL112 — apolipoprotein A-I and phosphatidylcholine — and reported that these levels rose more in participants who received CSL112 than in those who received placebo, with higher rises seen in the 6 g group than the 2 g 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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NCT03119571 · results posted 27 January 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03119571) enrolled 65 people in total — 31 who were initially admitted to a Cardiac Catheterisation Laboratory (CCL, a specialised heart procedure room) and 34 who were initially admitted to an Intensive Care Unit (ICU). All 65 participants completed the study with no dropouts. The trial was measuring survival to hospital discharge along with a disability score called the Modified Rankin Scale (mRS), which rates disability on a scale from 0 (no disability) to 5 (severe disability). The goal was to track how many participants survived to leave hospital while also having a disability score of 3 or lower — meaning they had, at most, moderate disability and were still able to walk without assistance. The reported data shows that, among those initially admitted to the CCL, approximately 67.7% of participants survived to hospital discharge with a disability score of 3 or lower. Among those initially admitted to the ICU, approximately 73.5% of participants met that same measure. No other outcome measures appear to have been submitted in the reported data — for example, detailed breakdowns of individual disability scores or longer-term follow-up figures were not reported in the data 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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NCT03318809 · results posted 27 January 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people in total — 6 with severely reduced kidney function and 6 healthy participants. All 12 completed the study with no one dropping out. The trial was measuring how a drug called AMG 986 behaves in the body (known as pharmacokinetics) — specifically, how much of the drug gets into the bloodstream, how quickly it reaches its highest level, and how long it takes for the body to clear it. The goal was to compare these figures between people with severely reduced kidney function and healthy individuals. The reported data shows that in the severely renally impaired group, the total amount of drug measured in the blood over time (AUClast) was 80,000 hr·ng/mL, compared with 64,500 hr·ng/mL in the healthy group. The peak level of the drug in the blood (Cmax) was reported as 10,600 ng/mL in the impaired kidney group and 7,520 ng/mL in the healthy group. The time it took to reach that peak was 1.1 hours versus 1.5 hours respectively. The reported half-life — meaning the time for the drug level to fall by half — was 18.4 hours in the impaired kidney group and 21.1 hours in the healthy group. A second measure of total drug exposure (AUCinf, which extends the calculation out to when the drug is fully cleared) was 80,800 ng·hr/mL versus 65,800 ng·hr/mL. For the secondary outcome, the reported data shows that 2 out of 6 participants in the severely renally impaired group and 1 out of 6 in the healthy group experienced a treatment-emergent adverse event (that is, an unwanted medical occurrence that happened after taking the drug). No serious adverse events — such as hospitalisation or life-threatening events — were reported in either 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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NCT03448406 · results posted 8 December 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03448406) enrolled 315 people with heart failure — 158 in the placebo group and 157 in the group receiving 10 mg of empagliflozin (a tablet taken daily). Most participants completed the 12-week trial (147 in the placebo group and 144 in the empagliflozin group). The trial was primarily measuring whether the medication changed how far participants could walk in six minutes compared to their starting point, and also looked at several secondary measures including heart failure symptom scores and fluid build-up in the body. The reported data shows that, for the main measure — change in six-minute walking distance at 12 weeks — the placebo group walked on average 5 metres more than their starting distance, while the empagliflozin group walked on average 10 metres more than their starting distance. At the six-week mark, the placebo group had increased their walking distance by an average of 1 metre, compared to 7 metres in the empagliflozin group. For the Kansas City Cardiomyopathy Questionnaire (a patient-reported symptom score out of 100, where higher is better), the placebo group's score improved by 2.08 points and the empagliflozin group's by 4.17 points. A separate breathlessness score (out of 7, higher is better) changed by +0.20 in the placebo group and +0.10 in the empagliflozin group. The reported data shows the fluid build-up score (lower is better) decreased by 0.28 points in the placebo group and 0.36 points in the empagliflozin group. For the measure asking patients to rate the overall severity of their heart failure symptoms on a 1–5 scale, the reported data shows counts of how many participants improved or worsened — for example, 70 placebo and 79 empagliflozin participants showed a one-category improvement from their starting score, while smaller numbers showed larger improvements or deterioration; the full breakdown across all categories was reported but no single summary figure was provided for this measure. 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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NCT03448419 · results posted 22 October 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03448419) enrolled 156 people in each of two groups — one group received a placebo (a dummy treatment) and the other received a 10 mg daily dose of empagliflozin, a tablet used in heart failure. The trial ran for 12 weeks and was measuring things like how far participants could walk in six minutes, how they rated their own heart failure symptoms, and scores from several questionnaires about quality of life and breathlessness. The reported data shows that for the main outcome — the change in distance walked in a six-minute walk test from the start to week 12 — the placebo group improved by an average of 18.0 metres, while the empagliflozin group improved by an average of 13.5 metres. For a heart failure symptom questionnaire score (KCCQ Total Symptom Score, where higher means feeling better, on a scale of 0–100), the placebo group's score improved by 3.65 points and the empagliflozin group's by 7.29 points. A breathlessness score (on a scale of 1–7, higher being better) improved by 0.40 points in both groups. A "congestion" score measuring fluid build-up signs (on a scale of 0–9, lower being better) decreased by 0.30 points in the placebo group and 0.61 points in the empagliflozin group. At six weeks, the six-minute walk distance had increased by 7.0 metres in the placebo group and 9.5 metres in the empagliflozin group. For a one-question rating of overall heart failure symptom severity, the reported data shows the numbers of participants whose scores improved, stayed the same, or worsened were broadly similar across both groups, though a full breakdown by category was not clearly separable from 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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NCT01920711 · results posted 29 September 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT01920711) enrolled 4,822 people with heart failure — 2,419 received a medicine called LCZ696 and 2,403 received valsartan, an existing heart medicine. Both groups had a form of heart failure where the heart's pumping function was relatively preserved. The trial was measuring how often participants experienced a combination of two events: death from a heart-related cause, or being hospitalised because of heart failure (counting every hospitalisation, not just the first one). The reported data shows that, over the course of the study, the LCZ696 group recorded a total of 894 of these combined events, compared with 1,009 in the valsartan group. Breaking that down, the LCZ696 group had 690 heart-failure hospitalisations versus 797 in the valsartan group, and 204 cardiovascular deaths versus 212. For overall deaths from any cause, 342 people in the LCZ696 group and 349 in the valsartan group died. A kidney-related combined measure (serious decline in kidney function, kidney failure, or kidney death) was recorded in 33 participants on LCZ696 and 64 on valsartan. The reported data also shows two measures of how participants felt. On a quality-of-life questionnaire about heart failure symptoms (scored 0–100, where higher means better), both groups' scores changed slightly from their starting points after eight months: the LCZ696 group's score changed by about −1.5 points and the valsartan group's by about −2.5 points (meaning both groups reported a small decline). For a separate scale rating day-to-day physical function, 347 participants on LCZ696 and 289 on valsartan showed improvement, while 202 and 221 respectively showed 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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NCT01985360 · results posted 10 September 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT01985360) enrolled 777 people in total — 388 in the "Invasive Strategy" group and 389 in the "Conservative Strategy" group. The trial was comparing two different approaches to managing a heart condition, and the main thing it was measuring was how many participants either died from any cause or had a heart attack (a myocardial infarction) over the course of the study. The reported data shows that in the Invasive Strategy group, 123 out of 388 participants experienced death from any cause or a heart attack. In the Conservative Strategy group, 129 out of 389 participants experienced the same outcome. The trial also reported what is called a "cumulative event rate" — which is an estimate of the overall likelihood of experiencing the combined outcome across the whole study period, similar to an overall percentage. The reported data shows this figure was 36.4% for the Invasive Strategy group and 36.7% for the Conservative Strategy group. These numbers were very close between the two groups. It is worth noting that the data as submitted does not include any additional secondary outcome measures beyond these two primary results, so no further figures 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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NCT02522481 · results posted 5 August 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 175 people, with 172 completing the study. All participants received a contrast agent called Lumason (also known as SonoVue) during a type of heart ultrasound test called a stress echocardiogram. The trial was measuring two main things: whether adding Lumason improved the clarity of the ultrasound images, and whether it improved the ability to detect or rule out a narrowing of the heart's arteries (coronary artery disease, meaning a blockage of 50% or more in any artery). The reported data shows that when it came to image clarity, between 78.8% and 93.7% of participants who had poor-quality images without the contrast agent had their image quality improve to an acceptable level after Lumason was given — this figure varied depending on which of the three independent readers assessed the images. For detecting or ruling out coronary artery disease, the reported results show the difference in correct detection rates (called sensitivity) between the contrast-enhanced scan and the unenhanced scan was 8 percentage points, and the difference in correct "ruling out" rates (called specificity) was 33.7 percentage points, both in favour of the contrast-enhanced scan. Regarding a scoring system used to measure how well the heart's inner wall could be seen across 17 sections, the reported data shows the score improved from an average of around 17.5–17.8 out of 34 without contrast to around 23.6–30.5 with contrast, depending on the time point measured. The reported data also shows that 21 participants experienced some form of adverse event (an unexpected or unwanted health experience recorded during the study), though the data as submitted does not provide a full breakdown of what those events were. This summary does not allow any conclusions to be drawn about whether Lumason is appropriate for any individual. 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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NCT01471522 · results posted 23 July 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT01471522) enrolled 5,179 participants in total — 2,588 in the "Invasive Strategy" group (where procedures such as angiography were used to look inside the heart arteries) and 2,591 in the "Conservative Strategy" group (where a less procedure-heavy approach was taken). The trial was measuring a combined outcome that tracked how many people experienced a serious heart-related event — specifically, death from a heart or blood vessel cause, a heart attack, or a hospital admission for unstable chest pain, heart failure, or a cardiac arrest that was successfully treated. The reported data shows that, for the main combined outcome, 318 participants in the Invasive Strategy group and 352 in the Conservative Strategy group experienced at least one of those events. When the trial looked at a slightly narrower version — counting only heart-related deaths or heart attacks (not hospitalisations) — 276 participants in the Invasive group and 314 in the Conservative group were recorded. For death from any cause at all, the reported numbers were very close: 145 in the Invasive group and 144 in the Conservative group. The trial also tracked estimated cumulative rates (roughly, the running chance of an event occurring over time) at several time points over the follow-up period. The reported data shows these rates started differently between the two groups in the earlier time points but appeared to come closer together — and in some cases crossed over — at the later 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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NCT00353522 · results posted 27 January 2020

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called dalcetrapib compared to a placebo (a dummy treatment with no active ingredient). A total of 135 people took part — 89 in the dalcetrapib group and 46 in the placebo group. Of those, 74 and 37 respectively completed the study. The trial was primarily measuring changes in HDL cholesterol (sometimes called "good cholesterol") levels in the blood after taking the treatment. The reported data shows that, on average, people in the dalcetrapib group had their HDL cholesterol rise by about 12.76 mg/dL (a unit used to measure substances in the blood), compared to a rise of about 0.50 mg/dL in the placebo group. Expressed as a percentage change, that was roughly 33.4% in the dalcetrapib group versus about 3.6% in the placebo group. The reported data also shows changes in a protein called CETP (which plays a role in how cholesterol moves around the body): its activity fell by about 56.5% in the dalcetrapib group compared to about 5.7% in the placebo group, while CETP levels in the blood rose by about 86.5% with dalcetrapib and fell slightly (about 4.9%) with placebo. Changes in other blood fats — including total cholesterol, triglycerides, LDL cholesterol ("bad cholesterol"), and proteins that carry cholesterol — were also measured and reported as percentage changes, with the dalcetrapib group generally showing larger shifts than the placebo group across most of these measures. The data on changes in mesenteric lymph nodes (small glands in the abdomen) was also reported, though the way those figures were structured in the submitted data makes a straightforward summary difficult to state with confidence. 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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NCT03099655 · results posted 9 January 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 440 people who received a specialised heart device lead called the Attain Stability Quad Lead — a wire used in cardiac resynchronisation therapy (a type of pacemaker treatment for heart failure). Of those 440 participants, 379 completed the study, while 61 did not. The trial was measuring two main things: how often the lead caused serious complications over six months, and how well the lead was able to deliver electrical signals to pace the heart without also accidentally stimulating the nearby phrenic nerve (a nerve whose stimulation can cause uncomfortable diaphragm twitching). The reported data shows that approximately 97.6% of participants were free from lead-related complications at six months — where a "complication" was defined as an event that caused death, stopped the device from working properly, or required a surgical procedure to fix. On the electrical performance side, around 96.3% of participants had at least one lead setting (out of 16 available settings) that could pace the heart at a low voltage (2.5 volts or less) without causing unwanted nerve stimulation. Additionally, approximately 94.2% of participants had a second usable lead setting meeting a slightly higher voltage threshold (4.0 volts or less). For secondary (additional) measures, the reported data shows the lead was successfully implanted in about 96.8% of cases. The average total procedure time was reported as 93 minutes, fluoroscopy time (the X-ray guidance time) as 19 minutes, and cannulation time (time to position the lead) as 7 minutes. The average pacing voltage threshold recorded at six months was reported as 1.07 volts. 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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NCT02389946 · results posted 1 August 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,334 people with blocked heart arteries who needed a procedure to open them up using a small mesh tube called a stent. Participants were placed into one of two groups: 884 people received the Orsiro stent (which releases a drug called sirolimus) and 450 received the Xience stent (which releases a drug called everolimus). Both are types of drug-coated stents commonly used to help keep arteries open. The trial's main goal was to measure how often a combination of serious heart-related events — called "Target Lesion Failure" — occurred within 12 months. This included heart-related death, heart attack affecting the treated artery, or the need to re-open the same treated area. The reported data shows that, at 12 months, the percentage of participants who experienced Target Lesion Failure was 6.32% in the Orsiro group and 8.90% in the Xience group. For the secondary measures, the reported data shows that device success (where the stent reduced the blockage to less than 30% using that stent alone) was recorded in 1,082 lesions in the Orsiro group and 566 in the Xience group. Procedure success (achieving the same result without a serious in-hospital cardiac event) was recorded for 827 participants in the Orsiro group and 401 in the Xience group. The reported data also shows that heart attacks were recorded in participants across both groups at multiple follow-up time points, with numbers ranging from 34 to 60 in the Orsiro group and 30 to 49 in the Xience group across those 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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NCT00430989 · results posted 17 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 7,112 people having surgery — 3,543 in a group that received nitrous oxide (laughing gas) as part of their anaesthetic, and 3,569 in a group that did not receive nitrous oxide. The vast majority of participants in both groups completed the study (around 3,483 and 3,509 respectively). The trial was measuring whether using nitrous oxide during surgery made any difference to the rate of serious events — including death, heart attack, heart failure, cardiac arrest, blood clots in the lungs, and stroke — within 30 days after the operation. The reported data shows that for the main (primary) outcome — a combined count of death and those serious cardiovascular events within 30 days — 283 participants in the nitrous oxide group and 296 participants in the no-nitrous-oxide group experienced at least one of those events. For the individual secondary outcomes, the reported numbers were: heart attack — 215 (nitrous oxide group) versus 219 (no nitrous oxide); cardiac arrest — 15 versus 19; pulmonary embolism (blood clot in the lungs) — 18 versus 22; stroke — 26 versus 19; and wound infection — 321 versus 311. The data as submitted reports only the raw counts of participants affected; no further breakdown or statistical interpretation was included in the structured results 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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NCT00651573 · results posted 14 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 722 people who were having heart surgery. Participants were split into two groups based on when they would receive a blood transfusion during or after their operation. One group of 365 people received a transfusion when their blood's red cell concentration (called haematocrit) dropped to 24%, while the other group of 357 people received a transfusion at the higher threshold of 28%. The trial was measuring whether the timing of that transfusion decision made a difference to a range of serious in-hospital complications, including death, stroke, lung problems, kidney failure, serious infections, heart rhythm problems, and the need for a second operation. The reported data shows that for the main outcome — the number of patients who experienced at least one of those serious complications while still in hospital — 59 out of 365 people (about 16%) were recorded in the 24% threshold group, compared with 68 out of 357 people (about 19%) in the 28% threshold group. For the additional outcomes measured, both groups had a median ICU stay of around 66–67 hours and a hospital stay of 10 days each. The reported number of blood transfusions received was recorded as 1 in both groups (though the reported data does not clarify whether this figure represents a median or another type of summary). Prolonged time on a breathing machine after surgery (more than 24 hours) was recorded in 22 participants in the 24% group and 18 in the 28% group. Irregular heart rhythm after surgery (atrial fibrillation) was recorded in 33 participants in the 24% group and 45 in the 28% 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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NCT02821962 · results posted 10 June 2019

According to the results reported on ClinicalTrials.gov, this trial involved 40 people taking part in a cardiac rehabilitation (CR) setting. Participants were split into two groups: 19 people received sedentary prompts via a wearable device called the VTAP (which vibrated to remind them to move after sitting too long), and 21 people received usual care. The main thing the trial was measuring was whether people were willing and able to use the wearable monitoring devices — in other words, how practical and acceptable they were to wear. A number of secondary measurements were also taken, including changes in sitting time, physical activity levels, body weight, BMI, and waist circumference over the 8-week study period. The reported data shows that for the primary outcome — willingness to wear the monitor again, rated on a 1-to-5 scale — 14 out of 17 people who completed the VTAP group scored 3 or above (meaning "maybe" or higher), compared with 19 out of 21 in the usual care group. For sitting time, the VTAP group showed an average change of −0.2% of the day spent sitting, while the usual care group showed an increase of 1.9%. For moderate-to-vigorous physical activity, the VTAP group changed by an average of +10.62 minutes per day and the usual care group by +9.34 minutes per day. Changes in body weight were −0.24 kg for the VTAP group and −0.08 kg for the usual care group. BMI changed by −0.07 kg/m² in the VTAP group and −0.11 kg/m² in the usual care group. Waist circumference changed by −0.98 cm in the VTAP group and −4.45 cm in the usual care group. It is important to note that this was a small study primarily designed to test whether the devices were practical to use, not to draw firm conclusions about health outcomes. The reported data shows only the raw average changes in each group — no comparative analysis between groups is included in what was submitted to ClinicalTrials.gov, so these numbers alone cannot tell us what differences, if any, were 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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NCT02656329 · results posted 22 May 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02656329) enrolled 321 people with heart failure — 164 in the AdreView™ group and 157 in the Standard of Care group. The trial used a heart imaging scan (AdreView™, also known as iobenguane I-123 scintigraphy) to guide decisions about whether participants should receive an implanted heart device. The main thing the trial was measuring was how many people in each group died from any cause during the study period. A number of secondary outcomes were also tracked, including deaths specifically related to the heart, hospital admissions, and serious complications from implanted heart devices. The reported data shows that, for the primary outcome of death from any cause, 3.0% of participants in the AdreView™ group and 3.2% in the Standard of Care group died during the study. For the secondary outcomes: cardiac-related deaths were reported in 1.2% of the AdreView™ group and 0.6% of the Standard of Care group; hospitalisation for a heart-related reason occurred in 7.3% versus 7.6%; and hospitalisation for any reason occurred in 17.1% versus 22.3%. A combined measure of serious heart rhythm events (including life-threatening irregular heartbeats and cardiac arrest) was reported in 1.2% of the AdreView™ group and 2.5% of the Standard of Care group. For device-related complications among participants whose scan result was above a certain threshold (H/M ≥1.6 — a measure from the scan indicating nerve activity in the heart), the reported data shows figures of 3.8% in the AdreView™ group and 15.0% in the Standard of Care group, though the trial data notes that zero events of one specific complication sub-type were recorded in the Standard of Care group. It is worth noting that the reported data shows zero participants recorded as having "completed" the study in either group, and all participants are listed as "not completed" — what this means for how the results should be interpreted was 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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NCT01663402 · results posted 18 March 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01663402) enrolled 9,462 people in each group — one group received a placebo (an inactive injection) and the other received a medicine called alirocumab, given every two weeks. The trial was measuring how often serious heart and blood vessel events — such as heart attacks, strokes, deaths from heart disease, or hospitalisation for unstable chest pain — occurred over the course of the study. Around 7,900 people in the placebo group and around 7,400 in the alirocumab group completed the study. The reported data shows that for the main outcome — the first serious heart or blood vessel event — 11.1% of participants in the placebo group and 9.5% of participants in the alirocumab group experienced such an event during the study. For the secondary outcomes, the reported data shows: any coronary heart disease event occurred in 14.3% (placebo) versus 12.7% (alirocumab); any major coronary heart disease event (heart disease death or heart attack) in 9.5% versus 8.4%; any cardiovascular event in 15.6% versus 13.7%; and the combined measure of death from any cause, non-fatal heart attack, or non-fatal stroke in 11.9% versus 10.3%. Death specifically from coronary heart disease was reported in 2.3% of the placebo group and 2.2% of the alirocumab group. These figures are the percentages of observed participants who experienced each event at least once during the trial period, as recorded and independently reviewed by a medical committee. 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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NCT01318811 · results posted 29 January 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants in total — 4 in the "dilute heparin" group and 8 in the "standard concentrated heparin" group. The trial was comparing two different ways of delivering heparin (a blood-thinning medication commonly used during kidney filtration machines) to patients receiving continuous kidney support treatment in hospital. The main thing being measured was how long the filter used in the kidney support machine kept working before it needed to be replaced. A secondary measure looked at whether patients experienced any serious bleeding episodes during treatment. The reported data shows that filters in the dilute heparin group lasted an average of around 22.5 hours, while filters in the standard concentrated heparin group lasted an average of 33 hours. It is worth noting that only 3 out of 4 participants completed the dilute heparin arm, and only 4 out of 8 completed the standard heparin arm, meaning the numbers involved are very small. Regarding the secondary measure, the reported data shows that zero major bleeding episodes were recorded in either group, though given the small number of participants, this figure should be interpreted with caution. 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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NCT01467466 · results posted 9 November 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 5,177 people across four groups. Each person received one of two drip fluids — either a saltwater solution (saline) or a sodium bicarbonate solution — and also took either a tablet of N-acetylcysteine (a type of antioxidant supplement) or a dummy tablet with no active ingredient. The trial was measuring whether these treatments, used around the time of a heart or blood vessel imaging procedure (angiography), made a difference to serious outcomes: death, the need for emergency dialysis (a machine to do the kidneys' job), or a lasting drop in kidney function in the 90 days after the procedure. The reported data shows the following numbers for the main outcomes. When comparing the two drip fluids, 111 out of roughly 2,585 people who received sodium bicarbonate experienced one of those serious outcomes, compared with 116 out of roughly 2,491 people who received saline. When comparing the two tablets, 115 out of roughly 2,583 people who took N-acetylcysteine experienced one of those serious outcomes, compared with 112 out of roughly 2,491 people who took the dummy tablet. No further breakdown of those individual outcomes (death, dialysis, or kidney decline separately) was included in the data reported to ClinicalTrials.gov. It is worth noting that a number of participants did not complete the study — ranging from 88 to 109 people across the four groups — though the reasons were not detailed 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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NCT01109992 · results posted 25 October 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people in total — 11 in a group that received a medication called regadenoson on its own, and 32 in a group that combined exercise with regadenoson. The trial was looking at a heart imaging procedure (a type of PET scan) and was measuring things like heart electrical activity, blood pressure changes, a heart stress marker in the blood (troponin T), the quality of the scan images, how well the heart was pumping, and blood flow through the heart muscle. All 11 participants in the regadenoson-only group completed the study, while 30 out of 32 completed it in the combined exercise-and-regadenoson group. The reported data shows the following for the primary measurements, which looked at certain signs that researchers monitored during the procedure. In the regadenoson-only group, 3 participants had a drop in systolic blood pressure (the top number in a blood pressure reading) of more than 20 mmHg, while none in the exercise-plus-regadenoson group did. On the other hand, 3 participants in the exercise-plus-regadenoson group showed changes on their heart electrical tracing (ECG), compared to none in the regadenoson-only group. No participants in either group showed abnormal levels of the heart stress marker troponin T. For the secondary measurements, the reported data shows that scan image quality (measured as a heart-to-liver ratio — a way of assessing how clearly the heart shows up compared to surrounding tissue) was broadly similar across both groups, ranging from 1.11 to 1.37. Heart pumping function (called ejection fraction — the percentage of blood the heart pumps out with each beat) was reported at between 58% and 62% across both groups and both scan sessions. Blood flow through the heart muscle at peak stress was reported as 1.82–1.85 mL/gm/min in the regadenoson-only group and 2.04–2.34 mL/gm/min in the exercise-plus-regadenoson group across the two scan sessions. 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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NCT00980057 · results posted 16 October 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT00980057) enrolled 478 people with heart failure who had a cardiac resynchronisation therapy (CRT) device implanted — a type of pacemaker that coordinates the heartbeat. Participants were split into two groups: 318 people received a newer "Adaptive CRT" (aCRT) pacing approach, and 160 received standard biventricular pacing (the conventional CRT method). The trial was measuring several things: how patients' overall heart failure status changed over time, how well the adaptive device's automatic settings matched settings chosen by ultrasound specialists, and whether the adaptive feature produced any concerning device settings. The reported data shows that, on the main measure of overall heart failure status (rated as "improved", "unchanged", or "worsened" based on hospital admissions, symptoms, and how patients said they felt compared to before the implant), 234 out of 318 people in the aCRT group and 114 out of 160 in the standard pacing group were counted as "improved." On the technical check comparing the adaptive device's automatic settings to those chosen by ultrasound specialists, a concordance score of 0.93 out of a possible 1.0 was reported (a score closer to 1 means the two sets of settings were more closely aligned). For the safety check on device settings, zero participants in the aCRT group were recorded as having a concerning setting event over the study period. On secondary measures, the reported data shows the aCRT group had the right side of the heart paced by the device 51.3% of the time, compared with 95.1% in the standard group. A measure of the heart's left chamber size (left ventricular end systolic volume index) changed by −8.3 units in the aCRT group and −10.5 units in the standard group. A measure of how much blood the heart pumps out with each beat (ejection fraction) changed by +3.9 percentage points in the aCRT group and +2.9 percentage points in the standard 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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NCT00798174 · results posted 28 September 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people in total — 16 in each group. It used a "crossover" design, meaning each participant was tested with both configurations at different times: one group tried the standard setup first, and the other tried the azygos coil setup first. The trial was measuring the **defibrillation threshold (DFT)** — that is, the minimum amount of electrical energy (measured in joules) needed to reset a dangerously abnormal heart rhythm — when using two different implantable defibrillator lead configurations: a standard SVC (upper chest vein) coil, and an azygos vein coil (a different vein near the spine). Of the 32 who started, 25 completed the study (12 from one group, 13 from the other). The reported data shows that the mean (average) defibrillation threshold measured with the azygos coil configuration was **10.4 joules**, while the mean threshold measured with the standard configuration was **12.2 joules**. In plain terms, this means that, on average across participants, a lower energy level was recorded as sufficient when using the azygos coil compared to the standard coil setup. No other outcome measures were reported in the submitted data. It is worth noting that the results data submitted was limited, and no additional secondary outcome figures were included in the ClinicalTrials.gov record. 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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NCT02625922 · results posted 21 September 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people in total — 14 in one group (who received the study drug serelaxin first, then a placebo) and 12 in the other group (who received placebo first, then serelaxin). This was a "crossover" trial, meaning everyone received both the study drug and a placebo at different times, allowing a direct comparison within the same individuals. The trial was measuring levels of certain proteins in the blood that are associated with the heart, taken after a cardiac stress test (exercise test), to compare readings when participants were on serelaxin versus when they were on placebo. The reported data shows that for the main (primary) outcome — a heart protein called high-sensitivity cardiac troponin I (hs-cTnI), which can indicate stress on heart muscle — no numerical results were reported in the data submitted to ClinicalTrials.gov. The same applies to a related secondary measure of that same protein at the 4- and 5-hour time points; those numbers were also not reported. For two other secondary measures, some numbers were submitted. A protein called NT-proBNP (another marker linked to heart stress) showed log-transformed values ranging from approximately 13.50 to 13.72 across the serelaxin and placebo groups at various time points. A third marker called H-FABP showed log-transformed values ranging from approximately 8.73 to 8.88 across both groups. Because these are "log-transformed" figures (a mathematical conversion used to handle a wide range of values), they do not directly represent the actual blood concentrations, and the reported data does not include a straightforward breakdown of the differences 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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NCT02115308 · results posted 19 September 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people in total — 15 in a healthy control group and 25 with coronary artery disease (a condition where the arteries supplying the heart become narrowed). Of those, 13 controls and 23 coronary artery disease participants completed the study, with 2 people in each group not finishing. The trial was measuring how well the heart muscle moves and squeezes during a stress test using a specialised heart scan called cardiac MRI. Specifically, it looked at two types of heart wall movement — "radial strain" (how much the heart wall thickens when it beats) and "circumferential strain" (how much the heart wall shortens around its circumference when it beats). The reported data shows that at rest, the healthy control group had a radial strain value of 0.158, while the coronary artery disease subgroups recorded 0.149 and 0.150 — where a higher positive number reflects more wall thickening. During stress, the control group's radial strain rose to 0.190, while the two coronary artery disease subgroups showed values of 0.167 and 0.141. For circumferential strain — where a more negative number reflects more shortening — the control group measured -0.181 at rest and -0.169 under stress, compared to values ranging from -0.140 to -0.121 at rest and -0.150 to -0.126 under stress in the coronary artery disease subgroups. The reported data also shows that heart segments with a particular scarring pattern visible on the scan (called Late Gadolinium Enhancement, or LGE) tended to have slightly different strain values compared to segments without it. Regarding monitored side effects, 7 out of 29 participants who received the stress-inducing drug (regadenoson) experienced a recorded adverse event, and no serious adverse events were reported — though the data does not provide further detail on the nature of those events. 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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NCT02379923 · results posted 18 July 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 163 people who had a complete blockage in a coronary artery — a condition called a chronic total occlusion (CTO). The trial was measuring how well a guidewire (a thin, flexible wire used by doctors during a heart procedure) could be navigated through or around the blockage. Of the 163 people who started, 158 completed the study, and 5 did not complete it (the reasons were not reported in the data). The reported data shows that the main goal — successfully positioning the guidewire in the right place without a serious in-hospital heart event — was achieved in 119 out of 163 participants. For the secondary measures, the data shows that the blockage was successfully crossed and blood flow restored in 145 participants. Serious in-hospital heart events (including cardiac death, repeat procedures on the treated area, or a heart attack after the procedure) were recorded in 31 participants. A perforation (an unintended hole) during the procedure was recorded in 21 participants, and a dissection (a tear in the artery wall) was recorded in 7 participants. The reported average procedure time was 118.5 minutes. 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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NCT01923740 · results posted 14 February 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 459 people in total — 227 in the Absorb BVS (bioresorbable scaffold) group and 232 in the XIENCE V (metal stent) group. The trial was comparing two different types of devices used to open blocked heart arteries: one that is designed to dissolve over time (Absorb BVS) and one made of a permanent metal material (XIENCE V). The main thing the trial was measuring was something called "in-segment late loss" — essentially, how much the narrowest point inside and around the treated artery had changed (in millimetres) between the procedure and one year later, as measured by X-ray imaging. The reported data shows that after one year, the average change in the narrowest point of the artery was 0.19 mm in the Absorb BVS group and 0.13 mm in the XIENCE V group (this figure was the same whether measured on a per-person or per-treated-artery basis). For the secondary outcomes, the reported data shows that the device was successfully delivered and positioned at the intended spot in 98.0% of target sites in the Absorb BVS group and 99.6% in the XIENCE V group. In terms of overall procedure success — meaning the device was placed correctly and the patient had no serious heart events before leaving hospital — 230 out of 230 participants in each group were recorded as successful. The reported data also shows that zero deaths (from heart-related, blood-vessel-related, or other causes) were recorded in either group 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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NCT02443402 · results posted 6 February 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 67 people in total — 36 in the sitagliptin group and 31 in the placebo group — with 60 of them completing the study. The trial was looking at blood sugar (glucose) levels in patients who had heart bypass surgery (coronary artery bypass grafting). Specifically, it was measuring how many people developed very high blood sugar during or after the surgery while in the intensive care unit (ICU), and how many needed ongoing insulin treatment once the initial intravenous (drip) insulin was stopped. The reported data shows that for the main outcomes, 22 out of 36 people in the sitagliptin group and 25 out of 31 in the placebo group developed high blood sugar episodes in the ICU serious enough to need insulin delivered through a drip. When it came to ongoing high blood sugar after the drip was stopped, the reported data shows 7 out of 36 in the sitagliptin group and 6 out of 31 in the placebo group needed a longer-acting insulin injection as a follow-up treatment. For the secondary (additional) outcomes, the reported data shows that 7 people in each group needed an insulin drip in the ICU. The average daily blood sugar level in the ICU was reported as 137 mg/dL for the sitagliptin group and 138 mg/dL for the placebo group. The average amount of insulin given per day in the ICU was reported as 37 units for the sitagliptin group and 83 units for the placebo group. The average time spent on intravenous insulin after leaving the ICU was reported as 12 hours for the sitagliptin group and 17 hours for 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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NCT01565941 · results posted 11 December 2017

According to the results reported on ClinicalTrials.gov, this trial (known as HALF-PINT) involved 713 participants in total — 360 in one group (called Tight Glycemic Control 1, or TGC-1) and 353 in the other (Tight Glycemic Control 2, or TGC-2). Both groups received a form of blood sugar management in an intensive care unit (ICU) setting, but with different target blood sugar ranges. The trial was measuring things like how long children spent in the ICU, how many died within certain timeframes, and how their development looked a year later. The reported data shows that the main thing being measured — the number of days participants were out of the ICU within a 28-day window (adjusted to account for those who died) — was 20 days for the TGC-1 group and 19.4 days for the TGC-2 group. For deaths within 28 days, the reported numbers were 47 participants in TGC-1 and 32 in TGC-2. For deaths within 90 days, the figures were 52 in TGC-1 and 40 in TGC-2. The number of days participants spent off a breathing machine within 28 days was reported as 21.8 days (TGC-1) and 20.9 days (TGC-2). Nearly all participants in both groups — 326 in TGC-1 and 324 in TGC-2 — were recorded as experiencing dysfunction in two or more organ systems at some point. For the developmental behaviour assessment taken about one year after leaving the ICU (scored on a scale of 20 to 160, where higher means better), the reported scores were 79.9 for TGC-1 and 79.4 for TGC-2. 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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NCT02293395 · results posted 13 November 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02293395) enrolled 3,037 people in total — 1,519 in the rivaroxaban (2.5 mg twice daily) group and 1,518 in the aspirin (acetylsalicylic acid, 100 mg once daily) group. The trial was comparing these two blood-thinning medicines, and the main thing it set out to measure was how many participants in each group experienced a clinically significant bleeding event that was not related to a type of heart bypass surgery (known as CABG). These bleeding events were grouped into three categories: major bleeds (such as bleeding in the brain, a large drop in blood levels, or a bleed that led to death within seven days), minor bleeds (a moderate drop in blood levels with visible signs of bleeding), and bleeds that needed medical attention but did not meet the criteria for major or minor. The reported data shows that, for this primary outcome, 80 out of 1,519 participants in the rivaroxaban group experienced one of these clinically significant bleeding events, compared with 74 out of 1,518 participants in the aspirin group. No secondary outcome measure data appears to have been included in the results submitted to ClinicalTrials.gov, 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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NCT00799903 · results posted 10 August 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT00799903) enrolled 15,828 people in total — 7,904 in the placebo group and 7,924 in the darapladib group. The trial was measuring whether darapladib, compared to a placebo (an inactive dummy pill), was associated with fewer serious heart and blood vessel events over the follow-up period. The main thing being tracked was the first time a participant experienced any one of three events: death from a heart or blood vessel cause, a heart attack (non-fatal), or a stroke (non-fatal). A number of additional, related outcomes were also tracked as secondary measures. The reported data shows that for the primary outcome, 819 people in the placebo group and 769 people in the darapladib group experienced one of those three serious events. For the secondary outcomes: when looking at a combined measure of major coronary (heart-related) events — including coronary heart disease death, heart attack, or urgent surgery to restore blood flow to the heart — 814 placebo participants and 737 darapladib participants had such an event. A broader combined measure of total coronary events recorded 1,269 in the placebo group and 1,159 in the darapladib group. Looking at individual outcomes, deaths from heart or blood vessel causes numbered 373 (placebo) and 359 (darapladib); heart attacks (fatal or non-fatal) numbered 405 (placebo) and 361 (darapladib); and strokes (fatal or non-fatal) numbered 152 (placebo) and 154 (darapladib). The reported data shows the numbers of participants who experienced events across both groups during the study period. No conclusions about whether the treatment "works" or is recommended can be drawn from these numbers alone, and the trial data does not tell us whether these differences are meaningful beyond the specific participants studied. 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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NCT01000727 · results posted 10 August 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 13,026 people in total — 6,522 received a placebo (a dummy tablet with no active ingredient) and 6,504 received a drug called darapladib at a dose of 160 mg. The trial was measuring whether darapladib made a difference to the number of people who experienced serious heart-related events, including heart attacks, deaths from heart disease, and the need for emergency procedures to restore blood flow to the heart. The reported data shows that for the main (primary) outcome — the number of people who had at least one of these major heart events during the follow-up period — 910 people in the placebo group and 903 people in the darapladib group had such an event. For the secondary outcomes, the reported numbers were: a combined measure of cardiovascular death, non-fatal heart attack, or non-fatal stroke occurred in 838 placebo participants and 824 darapladib participants; fatal or non-fatal heart attack occurred in 564 placebo participants and 547 darapladib participants; fatal or non-fatal stroke occurred in 130 placebo participants and 145 darapladib participants; death from cardiovascular causes occurred in 243 placebo participants and 268 darapladib participants; and death specifically from coronary heart disease occurred in 241 placebo participants and 211 darapladib participants. The reported data shows relatively similar numbers across most outcomes between the two groups, and in some measures the numbers were higher in one group and lower in another. No interpretation of what these differences mean clinically is provided here, as that requires expert assessment. 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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NCT00632021 · results posted 1 August 2017

According to the results reported on ClinicalTrials.gov, this trial involved 862 people in total — 432 in a "usual care" control group and 430 in an intervention group. The trial was measuring medication errors, specifically serious ones identified through interviews and a review of medical records. It also tracked how many participants had unplanned hospital admissions or emergency department visits. The reported data shows that, on average, the control group (usual care) had 0.95 serious medication errors per person, while the intervention group had 0.87 serious medication errors per person. For the secondary outcome, the reported data shows that 66 participants in the control group and 61 participants in the intervention group had unplanned hospitalisations or emergency department visits, out of 362 participants counted in each group for that measure. The trial was largely completed, with 428 of 432 control participants and 423 of 430 intervention participants finishing the study; the reasons for non-completion 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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NCT00853658 · results posted 25 November 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled just over 7,000 people in total across three groups — roughly 2,354 in each group. Participants were assigned to receive either a combination of two blood pressure medicines (aliskiren and enalapril together), aliskiren alone, or enalapril alone. The trial was measuring whether these treatments made a difference to two serious heart-related events: death from a heart-related cause, or being admitted to hospital because of heart failure. The reported data shows that, for the main outcome — the number of participants who experienced either a heart-related death or a heart failure hospitalisation — 770 people in the combination group had this event, compared with 791 in the aliskiren-alone group and 808 in the enalapril-alone group. The trial also looked at a quality-of-life questionnaire (called the KCCQ) at 12 months, which uses a score from 0 to 100 where higher numbers mean better health. The reported data shows that scores changed by around −5 points in the combination group, −6 points in the aliskiren-alone group, and −5 points in the enalapril-alone group from the start of the trial — meaning scores were slightly lower at 12 months across all three groups. For deaths from any cause, 595 participants in the combination group died during the study, compared with 654 in the aliskiren-alone group and 646 in the enalapril-alone 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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NCT00831441 · results posted 27 January 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT00831441) enrolled 3,687 people in the placebo group and 3,705 people in the apixaban 5 mg twice-daily group, for a total of 7,392 participants. The trial was measuring how often people in each group experienced serious heart and blood vessel events — specifically cardiovascular death (death from a heart or blood vessel cause), heart attack, or ischaemic stroke (a stroke caused by a blocked blood vessel). The study was stopped earlier than planned, with the final patient visit occurring in 2010, so results cover the period up until that early stopping point. The reported data shows the main (primary) outcome — the rate of cardiovascular death, heart attack, or ischaemic stroke — was 13.96 events per 100 patient-years in the placebo group, compared with 13.20 events per 100 patient-years in the apixaban group. ("Per 100 patient-years" is a way of counting how many events occurred, adjusted for how long people were in the study.) For the secondary outcomes, the reported data shows the rate of unstable angina (severe chest pain at rest) was 4.21 versus 3.95; stroke of any type was 1.85 versus 1.65; heart attack was 9.20 versus 8.59; and stent thrombosis (a blood clot forming in a coronary stent) was 2.21 versus 1.61 — all figures per 100 patient-years for placebo and apixaban respectively. The broader combined outcome of cardiovascular death, heart attack, unstable angina, or ischaemic stroke was reported as 17.95 versus 16.92 per 100 patient-years. 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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NCT01665053 · results posted 7 January 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 838 people in the Promus Element Plus stent group and 846 people in the SYNERGY stent group — a total of 1,684 participants. The trial was comparing two types of heart stents (small mesh tubes placed inside a blocked artery to keep it open) to see how often certain serious events occurred within 12 months. The main thing being measured was a combined event called "Target Lesion Failure" — meaning whether participants experienced a heart attack linked to the treated artery, needed a repeat procedure to reopen the same spot, or died from a heart-related cause. The reported data shows that for the primary measure — the percentage of participants who experienced Target Lesion Failure at 12 months — the result was 6.4% in both the Promus Element Plus group and the SYNERGY group. For the secondary measures, the reported data shows that 1.7% of the Promus Element Plus group and 2.6% of the SYNERGY group needed a repeat procedure specifically at the treated spot (Target Lesion Revascularisation). A repeat procedure anywhere along the treated artery (Target Vessel Revascularisation) was reported in 3.6% and 3.8% of participants respectively. The broader combined artery-related event rate (Target Vessel Failure) was 8.2% in both groups. Heart attacks of any kind were reported in 5.0% of the Promus Element Plus group and 5.4% of the SYNERGY group. Deaths from a cardiac cause were reported in 0.9% and 0.5% of participants 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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NCT00868439 · results posted 15 December 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 56 people in the patiromer group and 49 people in the placebo group (a placebo is a dummy treatment with no active ingredient). The trial was measuring changes in blood potassium levels over 28 days in people also taking a heart medication called spironolactone. High potassium in the blood can be a concern for people on this type of medication, and the trial was looking at whether patiromer — a powder taken by mouth — had any effect on those levels. The reported data shows that, on average, blood potassium levels fell by 0.21 units (mEq/L) in the patiromer group over the 28 days, while they rose by 0.23 units in the placebo group. For the secondary measurements: 7.3% of participants in the patiromer group had a potassium reading above a high threshold (5.5 mEq/L) during the study, compared with 24.5% in the placebo group. Nobody in the patiromer group left the study early because of high potassium, versus 6.1% in the placebo group. About 90.9% of patiromer participants had their spironolactone dose increased during the trial, compared with 73.5% in the placebo group. Additionally, 12.7% of the patiromer group had their potassium rise by 0.5 units or more from the start of the study, compared with 24.5% in the placebo group. The time-to-first high potassium reading was not reported for either 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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NCT01019135 · results posted 30 November 2015

According to the results reported on ClinicalTrials.gov, this trial looked at three different formats of cardiac rehabilitation programs for women: a women-only group, a mixed-gender (co-ed) group, and a home-based program. A total of 169 women started the trial — 55 in the women-only group, 59 in the co-ed group, and 55 in the home-based group. The main thing the trial was measuring was how many of the scheduled program sessions each group actually attended. Smaller numbers finished the trial than started: 35, 40, and 24 women completed it in each group respectively. The reported data shows that, for the primary measure of attendance, the women-only group attended an average of about 54% of their sessions, the co-ed group attended about 51%, and the home-based group attended about 58%. For the secondary measures, exercise capacity (a measure of how much oxygen the body uses during peak effort on a treadmill or bike test) was reported as roughly similar across all three groups — around 21 mL per kilogram per minute. Daily step counts, measured by a pedometer over seven days, were reported as approximately 5,297 steps per day for the women-only group, 6,130 for the co-ed group, and 6,694 for the home-based group. Self-reported leisure-time physical activity scores were similar across all three groups (around 29–31 on a scale where 20 or above suggests an "active" level). Diet scores were reported at around 202 for both the women-only and co-ed groups, and about 214 for the home-based group, where higher numbers indicate a lower-fat diet. Finally, medication-taking scores (on a scale of 0–4, where 2 or above suggests good adherence) were reported as approximately 3.7, 3.5, and 3.6 for the three groups 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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NCT00508716 · results posted 25 March 2015

According to the results reported on ClinicalTrials.gov, this trial involved 124 people who had recently been discharged from hospital. Participants were split into two groups: 61 people received usual care, and 63 people received a specially tailored program designed for people who find health information difficult to understand (sometimes called "low health literacy"). The trial was measuring whether people in either group were re-admitted to hospital or died within 90 days of leaving hospital. The reported data shows that in both groups, 48 out of the participants experienced either a re-hospitalisation or death within that 90-day period. That works out to roughly 79% of the usual care group and roughly 76% of the tailored intervention group. No other outcome measures were included in the data submitted to ClinicalTrials.gov, so any additional findings from this trial were not reported in this dataset. 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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NCT01435031 · results posted 25 November 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 222 participants, all of whom had a type of blocked heart artery known as a chronic total occlusion (CTO) — meaning the artery had been fully blocked for a long time. The trial was a single-group study, meaning everyone received the same treatment: a procedure to try to open the blocked artery, followed by placement of one of two types of stents (small mesh tubes used to keep an artery open), called XIENCE V or XIENCE PRIME. The trial tracked participants over four years, with check-ins at one month, six months, one year, two years, three years, and four years. Numbers of participants gradually decreased over time, with 171 people reaching the four-year follow-up point. The reported data shows that the trial measured several things. One key measure was a combined event called MACE — which stands for major adverse cardiac events — covering death, heart attack, or the need to repeat a procedure on the treated artery within one year. According to the results reported on ClinicalTrials.gov, 39 participants (out of the full enrolled group) and 15 participants (out of a narrower group who met all the study's specific requirements) experienced one of these events within one year. The trial also measured how often the procedure successfully opened the blocked artery using a guide wire; the reported figures for this ranged from roughly 79% to approximately 98%, depending on which specific definition and measurement method was used. The success rate for the balloon widening step that prepared the artery before stent placement was reported at around 93.8%. One additional measurement — the width of the narrowest point inside the artery before the procedure — was reported as an average of 0.01 mm, suggesting the artery was almost completely closed beforehand. 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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NCT01391507 · results posted 26 August 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01391507) looked at a drug called COR-1, tested at three different doses (20 mg, 80 mg, and 160 mg), compared against a placebo (a dummy treatment with no active ingredient). A total of 36 people took part — 10 in the placebo group, 8 in the 20 mg group, 6 in the 80 mg group, and 12 in the 160 mg group. The number who completed the study was smaller in each group: 6, 4, 2, and 5 respectively. The main thing the trial was measuring was a change in how well the heart's main pumping chamber was working — specifically the percentage of blood it pumps out with each beat, known as the left ventricular ejection fraction (LVEF). Readings above 55% are generally considered normal. The reported data shows that, for the primary measure of heart pumping function at six months, the starting figures across all groups were well below the normal range (roughly 29–35%). The reported change from those starting points was: placebo minus 1.6 percentage points, COR-1 20 mg plus 0.8 points, COR-1 80 mg plus 5.4 points, and COR-1 160 mg minus 0.9 points. For the secondary outcomes, a blood marker linked to heart stress (NT-ProBNP) was also measured at six months; the placebo group's level fell by about 806 units, while the 20 mg, 80 mg, and 160 mg groups showed increases of approximately 1,363, 393, and 1,110 units respectively. The reported data shows that for two other heart-function measurements (transmitral flow and E-wave velocity), most values were not able to be collected due to technical reasons, so those results are largely incomplete. For the six-minute walk test — how far participants could walk in six minutes — the reported changes from the starting point were: placebo plus 38.7 metres, 20 mg minus 8.7 metres, 80 mg plus 12.8 metres, and 160 mg plus 2.4 metres. It is worth noting that the number of participants across all groups was quite small, and a notable proportion did not complete the study, which the reported data acknowledges. These figures are the raw numbers submitted to the registry, and no conclusions about why the results look the way they do can be drawn from this summary 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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NCT00979199 · results posted 21 July 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 697 participants in total, all of whom underwent a combination of non-invasive heart imaging tests — including a type of CT scan of the heart's arteries (CTCA), nuclear imaging scans (PET or SPECT), and either an ultrasound or MRI of the heart. The trial was measuring how well these imaging methods could identify a condition called ischaemic heart disease (IHD), where the arteries supplying the heart become narrowed or blocked. Of the 697 people who started, 475 completed the study, and 222 did not complete it. The reported data shows that the main thing being measured was how many participants were diagnosed with IHD when they went on to have an invasive procedure — a direct look inside the heart's arteries (called invasive coronary angiography), sometimes combined with a pressure-based test called FFR to assess borderline narrowings. According to the results reported on ClinicalTrials.gov, 140 out of the participants received a diagnosis of IHD through this invasive procedure. A secondary part of the study aimed to compare the costs and diagnostic accuracy of the different imaging approaches used, however no numerical data for that secondary outcome was reported on 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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NCT01966042 · results posted 3 June 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01966042) involved a single group of 13 participants who received a cell therapy treatment. The trial was measuring changes in chest pain (angina) severity, heart function, and quality of life over 12 months. Eleven participants completed the trial, and two did not finish. The reported data shows that angina severity — rated on a scale from Class I (mild, only during intense effort) to Class IV (symptoms even at rest) — was tracked at 3, 6, and 12 months after treatment compared to the starting point. The reported median change figures were −2.0, −1.0, and −0.5 at those three time points respectively, meaning the group's middle score shifted toward lower (less severe) classes over time. A figure of 4.0 is also listed in the data, though the trial record does not clearly explain what time point or sub-measure this corresponds to, so it is not possible to describe it further. For heart pumping function (called left ventricular ejection fraction — a measure of how much blood the heart pumps out with each beat), the reported data shows values of 59.2% before treatment and 61.6% after. For the reduction in the area of the heart not getting enough blood flow (measured by a specialised scan), figures of −15% and −100% were reported, though the time points these correspond to were not clearly specified in the submitted data. Quality-of-life scores across multiple areas of daily life were also reported using a standard survey (SF-36, where higher scores mean less difficulty); the reported figures showed a range of scores before and after the procedure across six measurements, generally shifting upward, though one participant did not complete the post-procedure questionnaire. 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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NCT01863134 · results posted 31 October 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 140 people in total — 72 received a medicine called eptifibatide and 68 received a placebo (an inactive dummy treatment). All 140 participants completed the study. The trial was measuring a combined outcome called MACCE — short for Major Adverse Cardiac and Cerebrovascular Events — which tracked whether participants experienced death, a heart attack, a stroke, or needed to be re-hospitalised due to recurring reduced blood flow to the heart, over a follow-up period of up to 12 months. The reported data shows that, over those 12 months, 35.3% of participants in the placebo group experienced one or more of those events, compared with 13.8% of participants in the eptifibatide group. No other outcome measures were included in the structured results data submitted to ClinicalTrials.gov, so no further figures 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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NCT01506960 · results posted 18 October 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 64 participants who were already scheduled for a heart procedure called a cardiac catheterisation. The study was looking at whether two different imaging techniques — one called NIRS/IVUS (which uses near-infrared light and sound waves to look at the inside of arteries) and another called OCT (optical coherence tomography, a different light-based imaging method) — could detect fatty deposits, known as lipid-rich plaques, inside the coronary arteries (the blood vessels that supply the heart). Of the 64 people who started, 17 completed the study and 47 did not complete it; the reason for this was not reported in the data. The reported data shows that, among participants who had both imaging procedures performed during their heart procedure, 90% were found to have lipid (fatty material) detected by both the NIRS and OCT imaging systems. For a secondary measurement, the study looked at whether the depth of the fatty deposit made a difference to what NIRS detected. Plaques closer to the surface of the artery wall (described as "superficial," meaning less than 130 micrometres deep — roughly a fraction of a millimetre) had a reported average length of 5.5 mm, while plaques sitting deeper in the artery wall had a reported average length of 4.1 mm. These figures represent measurements taken during imaging procedures and describe what the two tools detected in this particular group of participants. No data on longer-term outcomes was reported in this record. 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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NCT01031095 · results posted 10 October 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 200 people in total — 100 in a group receiving low-dose intracoronary heparin (a blood-thinning medicine delivered directly into the heart's arteries) and 100 in a group receiving standard therapy. All 200 participants completed the trial. The study was measuring the rate of major adverse cardiac events, which are serious heart-related complications, in each group. The reported data shows that in the standard therapy group, 2% of participants experienced a major adverse cardiac event. In the low-dose intracoronary heparin group, the reported figure was 1%. It is worth noting that the data submitted to ClinicalTrials.gov does not include a direct statistical comparison between the two groups, so no further conclusions about the difference between these numbers can be drawn from the information provided. No secondary outcome measure data was 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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NCT00464087 · results posted 1 August 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 100 participants who were assigned to one of two blood-thinning medications — heparin (49 people) or bivalirudin (51 people) — during a heart procedure called a percutaneous coronary intervention (PCI), which is a procedure to open blocked arteries. An additional 29 people were screened but did not go on to take part in the study. The trial was primarily measuring whether participants experienced a serious bleeding event while in hospital, checked at three points: before a key step in the procedure, during the procedure itself, and after the procedure before leaving hospital. The reported data shows that, for two of the three primary measurements (before the procedure and during the procedure), zero participants in either the heparin group or the bivalirudin group experienced a major bleed. For the third primary measurement (after the procedure, before discharge), zero major bleeds were recorded in the heparin group, and one participant in the bivalirudin group was reported to have experienced a major bleed. For the secondary outcomes — which covered a range of other in-hospital events such as death, heart attack, complications at the site where the catheter was inserted, and blood clots — the reported data shows 4 participants in the heparin group and 4 participants in the bivalirudin group experienced one or more of these events. No further breakdown of those individual events 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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NCT00699998 · results posted 7 May 2013

According to the results reported on ClinicalTrials.gov, this trial compared two blood-thinning medicines — prasugrel and clopidogrel — in people who had been hospitalised with a type of heart condition (acute coronary syndrome) but were managed without immediate surgery to open blocked arteries. Participants were split into four groups based on which medicine they received and whether they were under or over 75 years of age. In total, 9,326 people started the trial (3,620 younger and 1,043 older participants on prasugrel; 3,623 younger and 1,040 older on clopidogrel), and the vast majority completed it. The trial tracked how many people experienced serious heart-related events over the study period. The reported data shows that the main thing being measured was the proportion of participants who experienced a combined event of cardiovascular death, heart attack, or stroke. For participants under 75, the reported figures were 10.06% in the prasugrel group and 10.96% in the clopidogrel group. For participants aged 75 or older, the figures were 24.64% (prasugrel) and 24.13% (clopidogrel). The reported data also shows results for several secondary measures — for example, when looking at cardiovascular death or heart attack alone, the figures were 9.61% versus 10.21% (under 75) and 22.53% versus 22.69% (75 and over). When death from any cause, heart attack, or stroke were combined, the reported percentages were 10.61% versus 11.12% (under 75) and 27.04% versus 26.83% (75 and over). The trial also measured platelet activity (how "sticky" blood cells were) and a heart-stress marker called BNP, with the reported numbers showing differences between age groups across both medicines. 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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NCT00607672 · results posted 10 October 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 86 people in total — 32 in a placebo group, 27 taking a medicine called ramipril (a type of blood pressure drug known as an ACE inhibitor), and 27 taking candesartan (a different type of blood pressure drug known as an ARB). The trial was looking at how these two medicines, compared to a placebo (a dummy treatment), affected the body's clot-dissolving system during and after open-heart surgery involving a heart-lung bypass machine. The main things being measured were blood levels of two proteins involved in that clot-dissolving process — t-PA antigen and PAI-1 — taken at several points in time around the surgery. The reported data shows that t-PA antigen levels (measured in ng/mL, a unit of concentration) started at roughly 14 ng/mL across all three groups before surgery, rose during and just after the bypass procedure, and then came back down afterwards. Peak readings reported were around 41 ng/mL for the ramipril group, 35 ng/mL for the placebo group, and 31 ng/mL for the candesartan group. For PAI-1 (another clot-related protein), levels also rose during surgery — reaching roughly 50 ng/mL in the candesartan group, 42 ng/mL in the ramipril group, and 40 ng/mL in the placebo group — before falling again after surgery. For the secondary measures, blood loss over 24 hours was reported as 437 mL (placebo), 470 mL (ramipril), and 511 mL (candesartan). The percentage of patients who needed to return to the operating room for bleeding was 3.6% (placebo), 8.3% (ramipril), and 4.5% (candesartan). Blood product transfusion rates and vasopressor drug use (medicines to support blood pressure) were also recorded across multiple time points, with figures varying across the three groups as detailed in the full dataset. 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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NCT01406990 · results posted 28 September 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 15 women who had been diagnosed with coronary artery disease (a condition where the arteries supplying the heart become narrowed). All 15 women completed the study — none dropped out. The trial was looking at how their bodies responded to a low daily dose of aspirin (81 mg), specifically measuring whether their blood platelets (tiny cells involved in clotting) were being sufficiently affected by the aspirin. Researchers used a measurement called the Aspirin Response Unit (ARU) to assess this. The reported data shows that the main outcome being tracked was the number of women whose bodies appeared not to respond adequately to the low-dose aspirin — defined in this study as having an ARU score above 550, which the researchers described as less than 50% reduction in platelet activity. According to the results reported on ClinicalTrials.gov, the number of participants meeting this definition of "low response" was reported as zero out of the 15 women tested. No secondary outcome measures were included in the submitted results data. It is worth noting that this was a very small study with only 15 participants, and no other outcome data beyond this single measure was reported in the submission. 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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NCT00916370 · results posted 1 June 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 505 participants across two groups. The first group, called the "Core Size Registry," included 401 people, while the second group, called the "Long Lesion Registry," included 104 people. The trial was looking at a type of heart stent (a small tube placed inside a blocked artery to keep it open), and was measuring a range of outcomes related to how the procedure went and what happened to participants' hearts afterwards. The reported data shows that the main outcome being tracked was called "Target Lesion Failure" — a combined measure of serious heart-related events including cardiac death, a type of heart attack related to the treated vessel, and the need to repeat a procedure on the same spot. In the Core Size Registry group, 4.5% of participants experienced this combined outcome, compared to 7.7% in the Long Lesion Registry group. For secondary outcomes, the reported data shows that the average procedure time (measured from the start to end of the procedure) was around 32.6 minutes in the Core Size group and 46.9 minutes in the Long Lesion group. The proportion of cases where the stent was placed successfully — meaning the treated artery was left with less than 50% blockage — was reported as 98.2% (Core Size) and 97.6% (Long Lesion) when measured on a per-blockage basis, and 97.8% (Core Size) and 94.3% (Long Lesion) when measured per person. Deaths from any cause were reported as 0.0% in both 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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NCT00292162 · results posted 1 June 2012

According to the results reported on ClinicalTrials.gov, this trial involved 41 people in total — 19 in the medical therapy group and 22 in the radiofrequency ablation (a procedure that uses heat energy to target specific areas of heart tissue) group. The trial was measuring whether either approach led to changes in heart pumping function and levels of a blood protein linked to heart stress, over a period of six months. The reported data shows that the main thing being measured was "left ventricular ejection fraction" — a way of expressing what percentage of blood the heart pumps out with each beat. At the start of the trial, the medical therapy group had an average score of 43% and the radiofrequency ablation group had an average of 36%. At six months, those figures were reported as 46% for the medical therapy group and 41% for the radiofrequency ablation group — representing a reported change of +2.8 percentage points and +4.5 percentage points respectively. For the blood protein measurement (called BNP — higher levels are generally associated with worse heart conditions), the medical therapy group started at an average of 1,846 picograms per millilitre and was reported at 1,931 at six months (a change of +85). The radiofrequency ablation group started at 2,550 and was reported at 2,354 at six months (a change of −196, meaning the level fell). 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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NCT00824434 · results posted 7 March 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people, and all 100 completed the study. The trial was testing a coronary stent called the PROMUS Element — a small mesh tube inserted into a narrowed heart artery to help keep it open. The study was measuring a range of cardiac events after the stent was placed, as well as looking at how the stent sat inside the artery over time. The reported data shows that the main (primary) outcome — a combined measure tracking whether any participant experienced a heart attack, cardiac death, a repeat procedure on the treated artery, or stent-related clotting — was recorded in 1.0% of participants (1 out of 100). Breaking that down into the separately reported figures: heart attack and death from any cause were each reported at 0.0%, and the need for a repeat procedure on the treated artery was reported at 1.0%. For the artery measurements taken by imaging, the reported data shows an average of 0.17 millimetres of "late loss" — meaning how much the inner diameter of the artery narrowed again after the stent was placed, as measured at a follow-up scan. Additionally, 5.7% of participants were reported to have an incomplete stent fit (where part of the stent did not press fully against the artery wall) immediately after the procedure, as detected by an internal imaging tool. It is worth noting that this was a single-group study, meaning there was no comparison group receiving a different treatment, so the numbers above describe only what was observed in the one group that received the PROMUS Element stent. 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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NCT01500434 · results posted 14 February 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 102 people who received a coronary stent called the PROMUS Element. The trial was looking at outcomes related to the treated area of the heart — specifically tracking a combination of serious events including repeat procedures to re-open the treated artery, heart attacks linked to that artery, and deaths linked to that artery. Of the 102 people who started the trial, 95 completed it, and 7 did not complete it (the reasons were not detailed in the data provided here). The reported data shows that the main (primary) outcome — called "Target Lesion Failure," meaning any of those serious heart-related events occurring at the specific treated spot — was recorded in 3.2% of participants. The trial also tracked this same measure at earlier time points as secondary outcomes, reporting 0.0% and 1.0% of participants at those earlier check-ins. A related measure called "Target Vessel Failure" — which looked at serious events across the whole treated blood vessel rather than just the specific spot — was reported at three time points: 0.0%, 2.0%, and 4.2% of participants respectively. The data does not specify which exact time points (for example, 30 days, 6 months, 1 year) each of these figures corresponds to, so those details 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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NCT01498692 · results posted 13 February 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 94 participants who all received a coronary stent called the PROMUS Element. The trial was measuring outcomes related to heart artery treatment, specifically tracking two main things: "Target Lesion Failure" (TLF) — meaning whether the treated section of artery needed to be re-treated, caused a heart attack, or led to a heart-related death — and "Target Vessel Failure" (TVF), a broader measure that looked at the same events but across the whole treated blood vessel. Of the 94 people who started, 86 completed the study and 8 did not. The reported data shows that for the primary measure (TLF, assessed in participants who received their assigned treatment as planned), 2.4% of participants experienced one of those events. For the secondary TLF measurements — which appear to reflect results at different follow-up time points — the reported figures were 3.2% and 0.0% of participants respectively. For the secondary TVF measures, which again appear to represent different follow-up time points, the reported figures were 6.7%, 4.3%, and 0.0% of participants. It is worth noting that the data submitted to ClinicalTrials.gov does not specify which time points each of these secondary measurements corresponds to, so a direct comparison between them cannot be made from this information 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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NCT00823212 · results posted 27 January 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,530 people in total — 762 in the PROMUS group and 768 in the PROMUS Element group. Most participants completed the study (727 and 735 respectively). The trial was comparing two types of heart stents (small mesh tubes placed inside narrowed arteries) by tracking a combined event called "Target Lesion Failure" (TLF) — which counted whether participants experienced a repeat procedure on the treated artery, a heart attack connected to that artery, or a heart-related death connected to that artery. The reported data shows that for the main (primary) outcome measured at one point in time, 2.9% of participants in the PROMUS group and 3.4% in the PROMUS Element group experienced a TLF event. The trial also tracked TLF and a related measure called "Target Vessel Failure" (TVF — similar but looking at the broader blood vessel, not just the treated spot) at additional time points. The reported data shows TLF figures of 1.4% vs 0.9%, and 1.9% vs 1.7%, and 3.2% vs 3.5% across those further time points for PROMUS and PROMUS Element respectively. For TVF, the reported figures were 1.4% vs 0.9%, and 2.0% vs 1.8% at two separate time points. No further detail about which time points these figures correspond to 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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NCT00783263 · results posted 14 September 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 440 people in total across four treatment groups. Participants were already taking a statin medication called rosuvastatin and were assigned to one of two approaches: adding a second cholesterol-lowering tablet called ezetimibe to their current rosuvastatin dose, or simply doubling their rosuvastatin dose. The trial ran for six weeks and was measuring changes in LDL-cholesterol — often called "bad cholesterol" — in the blood. The reported data shows that, looking at all participants together, those who added ezetimibe to their rosuvastatin had an average reduction in LDL-cholesterol of about 21.6% from their starting level, while those who doubled their rosuvastatin dose had an average reduction of about 5.6%. When the groups were looked at separately, participants who added ezetimibe to rosuvastatin 5 mg saw an average drop of about 18.6% compared with about 5.0% for those who moved up to rosuvastatin 10 mg alone; and those who added ezetimibe to rosuvastatin 10 mg saw an average drop of about 24.0% compared with about 6.1% for those who moved up to rosuvastatin 20 mg alone. The reported data also shows that 130 out of 221 participants in the add-ezetimibe groups reached a pre-set LDL-cholesterol target level, compared with 67 out of 214 participants in the doubled-dose groups. Additionally, 96 participants in the add-ezetimibe groups reached an LDL-cholesterol level below 70 mg/dL, compared with 38 in the doubled-dose 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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NCT00369382 · results posted 23 May 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 116 people in total — 59 in a group taking either cyclosporine or tacrolimus (common anti-rejection medicines used after organ transplants), and 57 in a group taking sirolimus (SRL), another anti-rejection medicine. The trial was measuring how well the kidneys were working over 52 weeks, using a calculation called creatinine clearance — essentially an estimate of how efficiently the kidneys filter waste from the blood. Both groups started with similar kidney function scores (around 57 units, measured in mL/min/1.73m²), well below the normal adult level of 90 or above. The reported data shows that, at the 52-week mark, kidney function scores had changed from where they started. In the cyclosporine or tacrolimus group, the score went down by an average of 1.35 units, suggesting a small decline from baseline. In the sirolimus group, the score went up by an average of 3.03 units, suggesting a small improvement from baseline. A second method of calculating kidney function (called the MDRD equation) showed a similar pattern across both groups over the same period. The reported data also shows changes in blood creatinine levels — a waste product the kidneys filter out — where higher levels can indicate the kidneys are working less efficiently. Across most time points measured, the cyclosporine or tacrolimus group showed small rises in blood creatinine, while the sirolimus group generally showed small falls, though the reported figures varied at different time points throughout the year. 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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NCT00670228 · results posted 11 February 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 33 people in total — 18 in the Intensive Insulin Therapy (IIT) group and 15 in the Standard Glycemic Care (SGC) group. The trial was looking at people who had experienced a heart attack, and it was comparing two different approaches to managing blood sugar levels in hospital. The main thing the trial was measuring was how much the size of the damaged area of the heart (called the "infarct") changed over 60 days, as measured by a cardiac MRI scan. It is worth noting that the trial was ended early, which resulted in a smaller number of participants than originally planned. The reported data shows that, for the primary measure — the change in the size of the heart damage over 60 days — both groups showed a reduction. The IIT group showed an average reduction of 7.84 percentage points of heart muscle mass, while the SGC group showed an average reduction of 15.72 percentage points. For one of the secondary measures — how well the heart was pumping (called "ejection fraction," meaning the share of blood the heart pushes out with each beat) — the reported figures at Day 3 were very similar: 43.08% for the IIT group and 43.43% for the SGC group. For a blood marker of inflammation called CRP, the IIT group recorded an average of 2.52 mg/L compared to 2.96 mg/L in the SGC group. The reported data also tracked serious cardiovascular events (such as heart failure, irregular heartbeat, stroke, and others) across both groups. The IIT group recorded 7 such events in total across the various categories, while the SGC group recorded a combined total of 4 events. Because the trial ended early and the number of participants was small, the figures above should be interpreted with care. 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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NCT00730132 · results posted 11 October 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 712 people in Russia who were already taking cholesterol-lowering medicines called statins but had not reached their target cholesterol levels. Participants had their statin treatment adjusted in one of three ways: their statin dose was increased, they were switched to a different statin, or a second medicine called ezetimibe was added to their existing statin. The trial was measuring how each of these three approaches affected participants' cholesterol levels — specifically their total cholesterol and a type called LDL cholesterol (often referred to as "bad" cholesterol). Of the 712 people who started, 557 completed the trial and 155 did not. The reported data shows that, of all participants, about 42% were switched to a new statin, around 32% had their statin dose increased, and about 26% had ezetimibe added to their existing statin. When looking at whether participants reached the recommended target level for total cholesterol (below 4.5 mmol/L), the reported figures were: 50.4% of those in the ezetimibe add-on group, 37.4% of those switched to a new statin, and 33.5% of those who had their dose increased. For the LDL cholesterol target (below 2.6 mmol/L), the reported figures were: 42.3% in the ezetimibe group, 33.9% in the new statin group, and 26.3% in the dose increase group. The reported data also shows percentage reductions in cholesterol levels compared to the start of the trial: total cholesterol fell by around 25.8% in the ezetimibe group, 22.8% in the new statin group, and 20.0% in the dose increase group, while LDL cholesterol fell by around 32.1%, 28.2%, and 26.8% 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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NCT00755131 · results posted 25 January 2010

According to the results reported on ClinicalTrials.gov, this trial (NCT00755131) involved 75 people in total — 37 in an exercise training group and 38 in a control group. All 75 participants completed the study with no drop-outs recorded. The trial was measuring several things in people with coronary artery disease, including levels of a protein in the blood called HMGB1 (which is linked to inflammation in the body), how much oxygen the body can use during peak physical effort (a measure of fitness), and how quickly the heart rate slows down in the first minute after exercise (a marker of how well the nervous system is regulating the heart). The reported data shows that, at the start of the study, average HMGB1 blood levels were similar between the two groups (27.6 ng/ml in the exercise group and 24.5 ng/ml in the control group). After six months, the exercise group's average HMGB1 level was reported as 11.7 ng/ml, while the control group's average was 20.5 ng/ml. For peak oxygen use, the reported data shows both groups started at similar levels (16.4 and 16.7 ml/kg/min respectively); at six months, the exercise group's average was reported as 21.0 ml/kg/min compared to 16.3 ml/kg/min in the control group. For heart rate recovery after exercise, starting averages were again similar (13.4 and 13.8 beats per minute); at six months, the exercise group averaged 19.7 beats per minute compared to 12.4 in the 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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NCT00552669 · results posted 20 August 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 200 people with newly developed blockages in their coronary arteries (the blood vessels supplying the heart). They were split into two equal groups of 100: one group received a bare metal stent (a small mesh tube used to hold an artery open) along with an oral medication called sirolimus taken by mouth, and the other group received a drug-eluting stent (a stent that is coated with medication and slowly releases it). The trial was measuring the difference in overall costs between the two approaches over 18 months, as well as tracking serious heart-related events and whether the treated blood vessel needed further procedures. The reported data shows that the average overall cost per person over 18 months was approximately US $5,483 in the oral sirolimus plus bare metal stent group, compared to approximately US $7,658 in the drug-eluting stent group. For the secondary outcome tracking serious cardiovascular events — which included death from any cause, heart attack, and stroke — the reported data shows 9 participants in the oral sirolimus group and 15 participants in the drug-eluting stent group experienced at least one of these events. Broken down further, the data reports 3 deaths in the oral sirolimus group versus 7 in the drug-eluting stent group, 6 heart attacks versus 9, and 0 strokes versus 1. For the number of treated blood vessels that needed a further procedure, the reported data shows 14 vessels in the oral sirolimus group and 15 in the drug-eluting stent group required additional treatment. It is worth noting that this trial included 100 participants per group, and the numbers reported are relatively small, so they should be interpreted with that context in mind. The figures above are simply what was recorded and submitted by the trial sponsors — they do not on their own tell us whether one approach is better, safer, or more suitable than another for any individual person. 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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NCT00300456 · results posted 25 March 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 650 adults across six treatment groups over a 12-week period. The six groups were: ABT-335 (a fenofibrate-based medicine) combined with either 20 mg or 40 mg of simvastatin (a cholesterol-lowering medicine); ABT-335 alone; and simvastatin alone at three different doses (20 mg, 40 mg, or 80 mg). The trial was measuring changes in several types of blood fats — including triglycerides (fats in the blood), HDL cholesterol (sometimes called "good" cholesterol), LDL cholesterol (sometimes called "bad" cholesterol), and total cholesterol — comparing levels at the start of the trial to levels at the end. The reported data shows the following average percentage changes in blood fat levels after 12 weeks. For triglycerides, the combination groups showed reductions of around 37–43%, the ABT-335 alone group showed a reduction of about 32%, and the simvastatin-only groups showed reductions of roughly 14–22%. For HDL ("good") cholesterol, the combination groups reported increases of about 18–19%, the ABT-335 alone group about 16%, and the simvastatin-only groups about 7–9%. For LDL ("bad") cholesterol, the combination groups reported reductions of about 24–25%, ABT-335 alone about 4%, and simvastatin-only groups about 22–41% depending on the dose. For total cholesterol, reductions ranged from about 12% (ABT-335 alone) to about 34% (80 mg simvastatin alone), with the combination groups falling in between at roughly 24–27%. The reported data also shows changes in two further measures — non-HDL cholesterol and VLDL cholesterol (another type of blood fat) — with reductions broadly similar in pattern to those described above across all groups. Not all participants who started the trial completed it; between 48 and 105 people per group finished the 12 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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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.