Reported trial results for Cardiomyopathy

57 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

• NCT05556343 · results posted 2 June 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT05556343) tested an investigational medicine called MYK-224. A total of 18 people took part in Part A (the initial dosing phase), of whom 17 completed that phase. Sixteen participants then moved into Part B, an open-label extension (meaning everyone knew what medicine they were receiving), though none had completed Part B at the time the results were submitted. The trial was primarily measuring a range of safety-related outcomes — specifically, unwanted medical events, irregular heart rhythms, and changes in basic body measurements like heart rate and blood pressure. The reported data shows that in Part A, 15 out of 18 participants experienced at least one adverse event (an unexpected or worsening medical occurrence during the study), while no participants experienced a serious adverse event (defined as one involving death, a life-threatening situation, or hospitalisation). Regarding irregular heart rhythms, 2 participants experienced at least one new or returning episode of a type called atrial fibrillation or flutter, and 1 participant experienced at least one episode of a more serious rhythm disturbance (ventricular tachyarrhythmia). One participant received at least one treatment from an implantable heart device (a defibrillator) or experienced a cardiac arrest that was resuscitated. The reported data also shows small average changes from the starting point in physical measurements during Part A: heart rate changed by an average of 0.9 beats per minute, the upper number in blood pressure (systolic) changed by an average of 2.5 mmHg, and the lower number (diastolic) changed by an average of 4.2 mmHg. No outcome data for Part B was 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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• NCT04023227 · results posted 11 May 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04023227) enrolled 922 people in total — 462 in the sacubitril/valsartan group and 460 in the enalapril group. The trial compared these two heart-related medicines in people with heart failure. It was measuring three things together as its main goal: how long it took before a participant died from a heart-related cause, how long it took before a participant was first admitted to hospital due to heart failure, and how much a particular blood marker (called NT-proBNP, a substance that rises when the heart is under stress) changed after 12 weeks. By the end of the study, 333 people in the sacubitril/valsartan group and 318 in the enalapril group had completed the trial. The reported data shows that for the main goal, the researchers used a method called a "win ratio" — essentially, they compared every person in one group against every person in the other group to see who fared better across those three measures. The sacubitril/valsartan group recorded 103,086 "wins" compared with 67,097 "wins" for the enalapril group, giving a win ratio greater than 1 in favour of sacubitril/valsartan. For the secondary measures, the reported data shows that 33.5% of people in the sacubitril/valsartan group and 36.7% in the enalapril group experienced a first hospitalisation due to heart failure or died from a heart-related cause. Death from any cause was reported in 27.9% of the sacubitril/valsartan group and 29.1% of the enalapril group. Sudden death or resuscitated cardiac arrest occurred in 46 participants taking sacubitril/valsartan and 39 taking enalapril. Emergency room visits for heart failure requiring intravenous (drip) treatment were recorded for 23 participants on sacubitril/valsartan and 21 on enalapril. Finally, the reported data shows that participants in both groups spent a very similar number of days alive and out of hospital within one year — an average of 339 days for the sacubitril/valsartan group and 338 days for the enalapril 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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• NCT05492500 · results posted 18 March 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT05492500) enrolled people with heart failure to test a medicine called ponsegromab. The main part of the trial (Cohort A) was a blinded comparison — meaning neither participants nor researchers knew who was getting which treatment — and included 433 people split across a placebo (dummy treatment) group and three different doses of ponsegromab: 100 mg, 200 mg, and 300 mg. A smaller, open-label group (Cohort B, where everyone knew what they were receiving) included 22 people across the same three doses. The trial's main focus was on how participants' heart failure symptoms and physical limitations changed over 22 weeks, as measured by a self-reported questionnaire called the KCCQ-23, where scores run from 0 (worst) to 100 (best). The reported data shows that the primary outcome — the change in a particular part of the KCCQ-23 questionnaire called the Clinical Summary Score (CSS), which covers symptoms and physical limitations — showed a reported average increase of 7.24 points in the placebo group and 7.56 points in the 300 mg ponsegromab group at 22 weeks. When all four Cohort A groups were compared as a secondary outcome, the reported average score changes were: placebo +7.21, ponsegromab 100 mg +5.57, ponsegromab 200 mg +6.25, and ponsegromab 300 mg +8.31. The reported data shows similar patterns across the other questionnaire sub-scores (overall summary and total symptom scores), with the 300 mg group generally showing the highest reported changes, though the differences between groups were modest across all measures. Results for Cohort B were not reported in the submitted outcome 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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• NCT04219826 · results posted 24 February 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04219826) looked at a drug called aficamten (also referred to as CK-3773274) in people with a heart condition called hypertrophic cardiomyopathy (HCM) — a condition where the heart muscle becomes abnormally thick. A total of 96 people took part across six groups: some had a type where blood flow out of the heart is partially blocked (obstructive HCM, or oHCM), and others had a type without that blockage (non-obstructive HCM, or nHCM). Some participants received aficamten, some received a placebo (a dummy treatment), and one group received aficamten alongside another medicine called disopyramide. The trial was primarily measuring how often participants experienced adverse events (unwanted health events) and whether a key heart function measure — the percentage of blood the heart pumps out with each beat (called left ventricular ejection fraction, or LVEF) — dropped below a certain threshold. The reported data shows that adverse events (any unwanted health events, not necessarily caused by the treatment) were recorded in 10 out of 14 participants in the Cohort 1 aficamten group, 7 out of 8 in the Cohort 1 placebo group, 11 out of 14 in the Cohort 2 aficamten group, 4 out of 6 in the Cohort 2 placebo group, 9 out of 13 in the Cohort 3 aficamten-plus-disopyramide group, and 28 out of 41 in the non-obstructive HCM aficamten group. More serious adverse events were recorded in smaller numbers: 1 participant each in the Cohort 1 aficamten and placebo groups, 1 in the Cohort 2 aficamten group, none in Cohorts 2 placebo or 3, and 4 in the non-obstructive HCM group. Regarding the heart pumping function threshold, the reported data shows that 0 participants in most groups fell below that level, while 2 participants in the Cohort 2 aficamten group and 3 in the non-obstructive HCM aficamten group did. The reported data also shows results for secondary measures looking at the pressure gradient (a measure of how hard blood has to push through a narrowed pathway out of the heart) at rest and during a breathing test. In the obstructive HCM groups receiving aficamten, resting pressure gradient changes from the starting point ranged from around –19 mmHg to –53 mmHg depending on the group and dose level, while the placebo groups showed much smaller changes (around –0.5 to –3.1 mmHg). The relationship between how much of the drug was in the blood and the change in pressure gradient was also reported as a negative number across all three obstructive HCM groups, meaning higher drug levels were associated with lower pressure gradient readings — though what this means clinically is not for this summary to interpret. 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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• NCT06269640 · results posted 18 December 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled just one participant who underwent a procedure called SESAME (SEptal Scoring Along Midline Endocardium). This is a technique that involves entering the heart muscle wall between the two lower chambers (the septum), navigating through it, and making a cut along it. The trial was primarily looking at whether the procedure could be completed successfully, and whether any serious safety events occurred during the hospital stay. The reported data shows that the one participant was recorded as having met the definition of technical success — meaning the procedure steps (entering the heart muscle, guiding a wire through, and making the cut) were all reported as completed. However, the reported data also shows that 2 inpatient safety events related to the procedure were recorded. The trial defined these safety events as things like death from any cause, stroke, or serious structural damage to the heart requiring further treatment. The exact nature of these 2 events is not broken down further in the submitted data. It is also worth noting that the one participant was recorded as not having completed the study. The reported data shows one additional finding under the secondary outcome: 1 event of complete heart block was recorded. Complete heart block is a disruption to the heart's electrical signalling that can require a permanent pacemaker to be fitted, and the trial notes this category also included cardiac arrest. No further detail about the outcome for the participant is provided in the submitted data beyond these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04153149 · results posted 21 October 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04153149) enrolled 655 participants in its main double-blind phase — 329 received a placebo (an inactive treatment) and 326 received vutrisiran. The trial was measuring outcomes in people with a heart condition related to a protein build-up disorder called transthyretin amyloid cardiomyopathy. The main thing the trial was tracking was a combined count of deaths from any cause and serious heart-related events (such as hospital admissions for heart problems or urgent heart failure visits). A separate, smaller group of participants — those not taking any other related background treatment — was also analysed on its own. After the main phase, some participants moved into an open-label extension period, where 221 former placebo participants and 241 former vutrisiran participants continued, though no completed-extension figures were reported in the data. The reported data shows that, in the overall group, 159 out of 329 placebo participants and 125 out of 326 vutrisiran participants experienced at least one of those combined death-or-heart-event outcomes during the double-blind period. In the smaller subgroup (those on vutrisiran alone, without other background therapy), the reported figures were 105 out of the relevant placebo participants and 76 out of the relevant vutrisiran participants. For physical fitness, participants did a six-minute walking test; the reported data shows the placebo group's walking distance declined on average by about 72 metres from where they started, while the vutrisiran group's declined by about 45 metres. In the single-therapy subgroup, those declines were about 92 metres for placebo and about 60 metres for vutrisiran. A heart-health quality-of-life questionnaire (scored 0–100, where higher is better) also showed declines in both groups: in the overall population, scores fell by an average of about 15 points in the placebo group and about 10 points in the vutrisiran group; in the single-therapy subgroup, the reported drops were about 19 points and about 11 points 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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• NCT00335036 · results posted 17 July 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 748 people in total — 525 in a group using "thin leads" and 223 in a group using "Gore PTFE-coated leads." (These are types of wires used with implantable heart devices called ICDs.) The trial was measuring how well each type of lead continued to function over time, how easy they were to remove when needed, and tracking certain events that occurred along the way. All participants who started the trial were recorded as completing it. The reported data shows that when looking at lead survival to five years (meaning the lead was still working as expected), 55% of thin leads and 92% of Gore PTFE-coated leads reached that point. When leads needed to be removed, the trial recorded 53 participants in the thin leads group and 12 in the Gore PTFE-coated group as having undergone an extraction procedure — the data does not break down further detail on removal techniques in the numbers provided. Regarding a secondary measure of "inappropriate shocks" (where the device fired when it may not have needed to), this was recorded in 33 participants in the thin leads group and 13 in the Gore PTFE-coated group. The reported data also shows that major complications during lead removal were recorded in 3 participants in the thin leads group and 3 participants in the Gore PTFE-coated group. These numbers are as submitted by the trial's sponsor, and no further context about the nature of those complications was included in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04766892 · results posted 20 March 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04766892) enrolled 30 people who all received mavacamten. All 30 were included in the safety and analysis populations, while 24 completed the study and 6 did not finish. The trial was primarily focused on tracking various types of medical events — called adverse events — that occurred while participants were taking the study drug. An adverse event simply means any unwanted medical occurrence that happens during a study, whether or not it is thought to be related to the treatment. The reported data shows that out of the 30 participants, 23 experienced at least one treatment-emergent adverse event (that is, a medical occurrence that arose during the treatment period). Five participants experienced what are classified as serious adverse events — meaning events considered more significant, such as those requiring hospitalisation or other important medical attention. Four participants had abnormal laboratory test results reported as adverse events, and four had abnormal vital signs (such as blood pressure or heart rate readings) reported as adverse events. Five participants had heart rhythm abnormalities reported as adverse events. For three specific categories of events considered of special interest — overdose symptoms, birth defects, and a significant drop in a measure of heart pumping function (called LVEF falling to 30% or below) — the reported count was zero participants for each. 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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• NCT02791230 · results posted 3 February 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT02791230) involved three groups of participants. One group (Cohort A) included 170 people who had received the study medicine, tafamidis, throughout both an earlier study and this extension study, and 82 people who had received a placebo (inactive treatment) in the earlier study before switching to tafamidis in this extension. A much larger second group (Cohort B) included 1,481 people who only joined during this extension study and received tafamidis. The trial was measuring, among other things, how long participants survived, how often they were hospitalised, and how many experienced adverse events (unwanted medical occurrences during the study period). The reported data shows that, for Cohort A, the median time until death or a related serious cardiac event (such as a heart transplant or implantation of a mechanical heart device) was approximately 58.7 months for those who had been on tafamidis throughout, compared with approximately 35.8 months for those who had started on placebo before switching to tafamidis. For cardiovascular-related events specifically, the reported figures were approximately 70.2 months and 40.8 months respectively for the same two groups. In Cohort B, 345 out of 1,481 participants experienced an all-cause mortality event (including transplants and mechanical assist device implantations), and 204 experienced a cardiovascular-related mortality event. Regarding hospitalisations, the reported average rate was approximately 1.67 hospital admissions per year for the continuous tafamidis Cohort A group, 1.84 per year for the placebo-then-tafamidis Cohort A group, and 0.96 per year for Cohort B. The reported data also shows that adverse events during the treatment period were recorded in 168 out of 170 participants in the continuous tafamidis Cohort A group, 79 out of 82 in the placebo-then-tafamidis Cohort A group, and 1,294 out of 1,476 treated participants in Cohort B. It is important to note that an adverse event as defined in this trial does not necessarily mean the event was caused by the treatment — it simply means an unwanted medical occurrence happened during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03366649 · results posted 16 January 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03366649) enrolled 34 participants in the main treatment group (called "UMA – Group 1"), of whom 26 completed the study. A second treatment group and a retrospective comparison group were listed but had zero participants recorded, so all reported results relate only to the 34-person group. The trial was measuring changes in the severity of a heart valve condition called functional mitral regurgitation — where the mitral valve leaks blood back in the wrong direction — as well as a range of other things including survival, serious heart-related events, quality of life, and physical fitness. The reported data shows that the average severity score for the valve leak (rated on a scale of 0 to 4, where higher means more severe) was 2.7 at the start and 0.7 at a later point in time. For the secondary measures, the reported data shows zero participant deaths at both time points measured. One participant experienced what the trial defined as a "major adverse cardiac event" (a combined measure covering death, stroke, worsening heart failure, hospitalisation for heart failure, or a repeat procedure on the valve) at one time point, with zero recorded at the others. A self-reported quality-of-life score (on a scale of 0–100, where 100 is the best imaginable health) was reported as 69.0 at one point and 76.9 at another. A heart failure symptom questionnaire score (where lower means less impact on daily life, out of a maximum of 105) was reported as 44.2 at one point and 30.9 at another. Finally, the distance participants could walk in six minutes was reported as 1,048.4 feet at one point and 1,210.6 feet at another. No data was reported for the comparison 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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• NCT00628745 · results posted 22 November 2024

  According to the results reported on ClinicalTrials.gov, this was a large registry-style study involving 6,718 people in total across five groups. The groups were defined by the dose of tafamidis they received — either 20 mg, 61/80 mg, a switch from 20 mg to 61/80 mg, or another dose — as well as a group of people who did not receive tafamidis. The study was primarily tracking unwanted medical events (called adverse events) that occurred during treatment, as well as deaths from any cause. It also collected information at the start of the study on how well participants could move around and carry out daily activities, using standard rating scales. The reported data shows that, among those treated with tafamidis 20 mg, 621 out of 1,648 participants experienced some kind of adverse event (an unwanted medical occurrence), and 331 experienced a serious adverse event. Of those, 47 had an adverse event considered by the investigating doctor to be related to the treatment, and 28 had a serious adverse event considered treatment-related. Smaller numbers were reported across the other dose groups. For all-cause deaths (deaths from any reason), the reported data shows 158 deaths among all tafamidis-treated participants combined, compared with 1,038 deaths among the untreated group — though the data does not report how long each group was followed for, which would be important context for comparing these numbers. For the movement and functioning scales recorded at the start of the study, the data shows how participants were distributed across the different stages, but no outcome data beyond baseline measurements was reported for these secondary measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03719040 · results posted 19 August 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 870 people into the Physiologic Pacing Registry. The study was looking at a type of pacemaker lead (the wire that delivers electrical signals to the heart) designed to pace the heart in a more "physiologic" — that is, more naturally timed — way. Of the 870 who joined, 849 went through an attempted lead implant procedure, and 667 people completed the full six-month follow-up period. The reported data shows that of the 849 people who had an implant attempted, 768 were recorded by their treating doctor as having had a successful implant. The trial also measured the minimum amount of electrical voltage needed to make the heart respond to the pacemaker signal — a figure called the "pacing capture threshold." For leads placed in a region of the heart called the His bundle, the reported average threshold at six months was 1.59 volts. A separate, additional analysis looked at leads placed in a nearby area called the left bundle branch, where the reported average threshold at six months was 0.79 volts. It is worth noting that 203 participants did not complete the study, though the reasons for this were not broken down in the submitted data. The trial only followed participants for six months, so longer-term figures were 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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• NCT04561778 · results posted 7 August 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04561778) enrolled 100 people in total — 50 in each group. One group received a heart pacing approach called HOT-CRT, and the other received a more established pacing approach called biventricular (BiV) pacing. Both are types of cardiac resynchronisation therapy, which use a small implanted device to help the heart's chambers beat in a more coordinated way. The trial was measuring changes in heart pumping function over six months, as well as tracking serious complications and other health events. The reported data shows that the main measurement — how much the heart's pumping ability (called "left ventricular ejection fraction," or LVEF, a percentage score of how well the heart pumps blood) changed after six months — was an average increase of 12.4 percentage points in the HOT-CRT group and 8.0 percentage points in the BiV pacing group, compared to where each participant started. For the safety measure, 49 out of 50 participants in the HOT-CRT group and 48 out of 50 in the BiV pacing group were reported as free from major complications or the need for a lead (wire) revision. On a secondary measure looking at a combination of events — including needing to switch treatment groups, dangerous heart rhythm episodes, hospitalisation for heart failure, or death — 9 participants in the HOT-CRT group and 14 in the BiV pacing group experienced at least one of those events. A further secondary measure counted how many people had a more than 5 percentage point improvement in their pumping score: 35 in the HOT-CRT group and 27 in the BiV pacing 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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• NCT04424914 · results posted 19 July 2024

  According to the results reported on ClinicalTrials.gov, this study (NCT04424914) enrolled a total of 347 people across three groups: 56 people who were diagnosed with a specific type of heart condition called ATTR-CM (a disease where a protein called transthyretin builds up in the heart), 259 people who did not have ATTR-CM, and 32 people whose results could not be fully evaluated. All participants had a form of heart failure known as "heart failure with preserved ejection fraction" (HFpEF), meaning their heart pumps normally but is too stiff — and the trial was designed to measure how common ATTR-CM is among people with this type of heart failure who were considered to be at risk of having it. The reported data shows that, among all evaluable participants with HFpEF, 17.8% were found to meet the criteria for an ATTR-CM diagnosis. When broken down by subgroups, the reported figures varied: by region, the percentage ranged from roughly 5% to 24%; and by gender, around 10% of female participants and 24% of male participants were reported to have ATTR-CM. Across age groups, the reported figures ranged from 0% in one age bracket up to about 44% in another, though the data does not specify which exact figure corresponds to which subgroup label. Among those diagnosed with ATTR-CM, the reported data shows 47 had the "wild-type" form (not inherited), 7 had a hereditary form, and 2 were not classified. A blood marker related to heart stress (NT-proBNP) was also measured: the reported median level was 2,470 ng/L in those with ATTR-CM, compared with 817.5 ng/L in those without — these are simply numbers that were recorded, and what they mean clinically is not stated 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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• NCT03842163 · results posted 12 February 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 812 participants in total, though the main analysis included 766 people who completed the study. The trial was looking at people who had an unexplained thickening of the heart's main pumping chamber (called left ventricular hypertrophy, or LVH) and aimed to measure how often a specific type of protein build-up in the heart — known as amyloidosis — might be behind that thickening. To do this, researchers used a special nuclear imaging scan of the heart, as well as blood and genetic tests. The reported data shows that, among the 766 participants in the main analysis group, 32% showed signs of abnormal protein deposits in the heart on the imaging scan. Of that same group, 17.9% were found to have a form of this condition called transthyretin amyloidosis (where a specific protein called transthyretin builds up abnormally). When also counting those with a suspicion of a related but different type of protein build-up (called light chain amyloidosis), the combined figure rose to 25.2%. Among a smaller subgroup of 245 participants who went on to have genetic testing, 6.5% were found to carry a gene variant linked to an inherited form of the condition. In slightly different subgroups of participants, that inherited form was reported at 6.9% and 8.7% respectively. The reported data shows only what was measured and counted in each group — no comparison was made against a control or placebo group in these results, as this was an observational study tracking what was found during the diagnostic process. The figures above reflect how common these findings were in this particular group of people with unexplained heart thickening. 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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• NCT03997383 · results posted 18 October 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03997383) involved 360 people in total — 179 received a placebo and 181 received patisiran during the initial blinded phase, where neither participants nor researchers knew who was getting which treatment. After that phase, participants moved into an open-label extension where everyone received patisiran. The trial was measuring things like how far participants could walk in six minutes, how they felt about their heart condition using a questionnaire, and whether there were differences in deaths, hospital visits, or urgent heart failure appointments between the two groups. The reported data shows that after 12 months in the blinded phase, the group who received the placebo walked an average of about 21 metres less than they had at the start, while the group who received patisiran walked an average of about 8 metres less than they had at the start. On the heart condition questionnaire (scored from 0 to 100, with higher meaning better), the placebo group's score dropped by around 3.4 points on average, while the patisiran group's score changed by less than half a point. For the combined measure looking at deaths, hospital visits, and walking distance together, the reported data shows a "win ratio" (a way of counting how often one group fared better than the other in head-to-head comparisons) of 1.22 among those already taking another medicine called tafamidis, and 1.28 among those who were not — both above 1, which in this method indicates the patisiran group had more favourable comparisons. For the measure combining deaths and all hospital or urgent heart failure visits across all participants, a ratio of 0.883 was reported (a figure below 1 is described in the study as a favourable direction for patisiran); among those not on tafamidis, that figure was 0.997. 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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• NCT00701220 · results posted 18 July 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 9 people in total — 3 with ischemic cardiomyopathy (a type of heart weakness caused by reduced blood supply) and 6 with non-ischemic cardiomyopathy (heart weakness from other causes). Of those, 5 people completed the study (1 from the ischemic group and 4 from the non-ischemic group), while 4 did not complete it. The trial was measuring changes in certain cells in the blood called endothelial progenitor cells (EPCs) — early-stage cells that circulate in the bloodstream — using a laboratory test called the Aldefluor assay, which detects a particular marker found on these immature cells. The reported data shows two main measurements. For the first measure — the change in the percentage of EPCs — the ischemic cardiomyopathy group showed a change of −10.01% (a decrease), while the non-ischemic cardiomyopathy group showed a change of +5.19% (an increase). For the second measure — the overall percentage of Aldefluor-positive cells (cells carrying the marker the test looks for) at the time of measurement — the ischemic group recorded 6.37% and the non-ischemic group recorded 5.7%. No other outcome data was reported beyond these figures. It is worth noting that this was a very small trial with only 9 participants, and the reported data reflects only what was 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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• NCT03103490 · results posted 7 April 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 28 participants, all of whom completed the study with no drop-outs. The trial was looking at a radioactive imaging agent called 18F-FSPG, used with specialised body scanners (PET/MRI or PET/CT), to see whether it could pick up signs of sarcoidosis — an inflammatory condition — in the heart and elsewhere in the body. The reported data shows that when the scan images were reviewed for signs of sarcoidosis in the heart, 2 out of the 28 participants showed patterns of 18F-FSPG uptake (meaning the imaging agent was absorbed in ways that the researchers considered a positive finding for possible heart involvement). For the second measure — looking across the whole body for signs of sarcoidosis outside the heart — the reported data shows that 11 out of 28 participants had uptake patterns considered a positive finding in other parts of the body. It is worth noting that this trial had only one group, so there was no comparison group — all 28 participants received the 18F-FSPG imaging agent. No other outcome figures were reported in the submitted data beyond these two counts. 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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• NCT03458130 · results posted 16 November 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03458130) enrolled 49 people in total, split across three groups: 16 people received a lower dose of AG10 (400 mg), 16 received a higher dose of AG10 (800 mg), and 17 received a placebo (a dummy treatment with no active ingredient). All 49 participants completed the trial. The study was measuring changes in basic body signs — blood pressure (both the "top" and "bottom" numbers), heart rate, breathing rate, and body temperature — over 28 days. It also looked at a laboratory measure of how stable a protein called TTR remained in participants' blood samples. The reported data shows that across all three groups, most of the body sign measurements shifted by only small amounts over the 28 days. For the "bottom" number of blood pressure (diastolic), changes ranged from about −2.6 to −4.9 mm Hg across the groups. For the "top" number (systolic), changes ranged from about −2.7 to −8.1 mm Hg. Heart rate changes ranged from about −0.4 to −7.3 beats per minute, breathing rate changed by up to about −1.1 breaths per minute, and body temperature shifts were all less than 0.25 degrees Celsius. These changes were seen across all groups, including the placebo group. For the laboratory test measuring TTR protein stability, the reported data shows that 14 out of 16 participants in the 400 mg group and 15 out of 16 in the 800 mg group reached a 95% or higher stabilisation threshold, while no participants in the placebo group reached that threshold. At the higher 99% threshold, 11 out of 16 (400 mg) and 13 out of 16 (800 mg) reached that level, again compared with zero 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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• NCT03442764 · results posted 9 August 2022

  According to the results reported on ClinicalTrials.gov, this trial involved 59 people split across three groups — Group 1 (19 people), Group 2 (21 people), and a placebo group (19 people). The trial was primarily measuring how often participants in each group experienced unwanted health events (called adverse events) after starting the study treatment. Nearly all participants finished the trial; only one person in Group 1 did not complete it. The reported data shows that when looking at participants who experienced at least one unwanted health event during the study, 88.9% of Group 1, 90.5% of Group 2, and 68.4% of the placebo group reported at least one such event. For more serious unwanted health events — those considered significant enough to be classed as "serious" — the reported data shows that 11.1% of Group 1, 9.5% of Group 2, and 21.1% of the placebo group experienced at least one. These figures simply describe what was recorded and counted; they do not on their own tell us whether the treatment caused these events or how they compare to what might normally be expected. It is worth noting that the trial's primary focus was on tracking and counting these health events, not on measuring whether a treatment produced a particular benefit. No secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04066738 · results posted 18 May 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 2 participants, all of whom had scarring of the heart muscle (known as myocardial scar). Both participants completed the study. The trial was looking at how a pacing technique called "multipoint pacing" (MPP) — where a pacemaker-like device stimulates the heart from more than one spot at a time — affected the pumping function of the heart. Specifically, it measured changes in how forcefully and quickly the heart's main pumping chamber (the left ventricle) could build up pressure, compared to the heart's own natural rhythm and to a standard pacing approach. The reported data shows two main findings, both expressed as a percentage change in a measure of how quickly the heart builds pressure (called LV dP/dT max — essentially a snapshot of pumping force). First, when comparing multipoint pacing to the heart's spontaneous (natural) activation, the reported average difference between pacing near the scarred area versus pacing in healthier heart tissue was 12.97%. Second, when comparing multipoint pacing to standard single-site pacing (the conventional approach), the reported average difference between the two pacing locations was 13.49%. No additional breakdown of results by individual participant or location was reported in the submitted data. It is worth noting that with only 2 participants, this was a very small study, and the reported numbers reflect a very limited sample. 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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• NCT02351856 · results posted 31 March 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02351856) enrolled 8 participants, all of whom received the study drug ARRY-371797. None of the 8 participants completed the study — all 8 left before it finished, though the reasons for this are not detailed in the reported data. The trial was focused on monitoring and recording a range of health measurements in participants while they were taking the study drug, including any unwanted medical events (called adverse events), blood test results, physical examination findings, vital signs (such as blood pressure and heart rate), and heart rhythm recordings (ECGs). The reported data shows that 6 out of 8 participants experienced treatment-emergent adverse events (unexpected medical occurrences that happened during or shortly after taking the study drug), and 8 out of 8 experienced serious adverse events as defined by the study. All 8 participants had findings noted during physical examinations, and 8 out of 8 also had findings outside the pre-set normal ranges on their ECG heart recordings. Six out of 8 participants had vital signs — such as blood pressure, heart rate, or temperature — that fell outside the study's pre-specified ranges at some point. The reported blood and chemistry test results showed various shifts in laboratory values across participants, with numbers of people affected varying depending on the specific measurement; these are presented in the data as changes from their starting levels to the worst level recorded during the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03022461 · results posted 2 December 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people, all of whom were already taking part in an ongoing study of the HM3 heart pump device (a mechanical device implanted to help a failing heart pump blood). Of the 25 who started, 22 completed the study and 3 did not. The trial was measuring how many participants survived over time, as well as tracking their quality of life, physical function, heart-failure symptoms, adverse (unwanted) events, and whether the device had any malfunctions. The reported data shows that 61% of participants survived over the study period. For quality of life, participants were asked to rate their own health on a scale from 0 to 100 (where higher means better quality of life); the reported average score was 69.3 out of 100. Physical function was measured by how far participants could walk in six minutes — the reported average distance was 294.4 metres. Heart-failure symptoms were graded using a standard four-level scale (Class I meaning no noticeable limitation through to Class IV meaning severe limitation even at rest); the reported data shows 9 participants were at Class I, 10 at Class II, 2 at Class IIIA, and none at Classes IIIB or IV. Regarding adverse events, the reported data shows numbers of participants experiencing various unwanted events (3, 9, 2, 3, 1, and 0 participants across the categories listed), though the specific labels for each category were not reported in the data provided here. No participants were reported to have experienced a device malfunction. 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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• NCT03470545 · results posted 4 October 2021

  According to the results reported on ClinicalTrials.gov, this trial (known as EXPLORER-HCM) enrolled 251 adults with a heart condition called hypertrophic cardiomyopathy — 123 people received the investigational drug mavacamten and 128 received a placebo (a dummy treatment with no active ingredient). The trial ran for 30 weeks and was primarily measuring whether participants achieved a meaningful improvement in exercise capacity (how well the heart and lungs work during exercise) and/or their functional symptom class, a doctor-rated score of how much a heart condition limits daily activity. The reported data shows that for the main measure, 45 out of 123 people in the mavacamten group met the definition of a clinical response, compared with 22 out of 128 in the placebo group. For the secondary measures, the mavacamten group showed an average change in a heart pressure reading (peak pressure in the heart's outflow tract after exercise) of –47 mmHg (millimetres of mercury, a unit of pressure), compared with –10 mmHg in the placebo group. The reported data shows an average change in exercise oxygen capacity of +1.4 units (mL/kg/min) for mavacamten versus –0.05 for placebo. Eighty out of 123 people in the mavacamten group improved by at least one symptom class, compared with 40 out of 128 in the placebo group. On a patient-reported quality-of-life questionnaire (scored 0–100, higher is better), the average score improvement was 13.6 points for mavacamten versus 4.2 for placebo. On a shortness-of-breath symptom questionnaire (scored 0–18, lower is better), the average change was –2.8 for mavacamten versus –0.9 for placebo. 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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• NCT02568072 · results posted 5 August 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02568072) enrolled 120 participants in a single study group, of whom 68 completed the study and 52 did not. The trial was measuring changes in heart muscle structure — specifically, the thickness and complexity of different layers of the heart wall — before and after a period of around seven months. These measurements were taken using two types of heart imaging: ultrasound (echocardiography) and a cardiac MRI scan (cardiac magnetic resonance imaging). The reported data shows the following numbers for the heart muscle measurements at the start of the study (baseline) and again at seven months. For the compacted layer of heart muscle (the denser, more organised part), echocardiography recorded an average thickness of 0.53 cm at baseline and 0.56 cm at seven months; MRI recorded 0.80 cm at baseline and 0.85 cm at seven months. For the non-compacted layer (the more irregular, spongy-looking part), echocardiography recorded 0.65 cm at baseline and 0.58 cm at seven months; MRI recorded 0.80 cm at both time points. A measure called "fractal dimension" — which describes how complex or intricate the inner surface of the heart wall looks — was also recorded; both the average and peak values sat at approximately 1.20 and 1.36 at baseline and seven months respectively (on a scale of 1 to 2, where a higher number means a more irregular surface). For the secondary outcome, peak oxygen consumption — a measure of cardiovascular fitness during exercise — was reported as 37.9 ml/kg/min at baseline and 38.4 ml/kg/min at seven months. One additional planned measure (a blood marker called NTproBNP) was not collected, as the trial investigators noted no heart remodelling was observed and reported that collecting this data would not add value; no figures were provided for that outcome. 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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• NCT00935012 · results posted 5 January 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT00935012) enrolled 31 people, all of whom received tafamidis 20 mg. The trial was looking at a heart condition and tracked participants over up to 60 months (five years). It measured how participants felt overall compared to their last visit (using a self-reported scale called the Patient Global Assessment), how much their heart-related physical limitations changed over time (using a standard four-level scale called the NYHA classification), and how far they could walk in six minutes. Notably, only 2 of the 31 participants were recorded as having completed the study, while 29 did not complete it — the reasons for this are not detailed in the reported data. The reported data shows that at the 12-month mark, when participants were asked how they felt compared to their previous visit: none reported being "markedly improved," about 16% reported being "moderately improved," about 10% "mildly improved," about 52% "unchanged," about 13% "mildly worsened," and about 10% "moderately worsened," with none reporting being "markedly worsened." At 60 months, among the smaller number still in the study, the reported figures were: none "markedly improved," about 8% "moderately improved," about 8% "mildly improved," 50% "unchanged," about 17% "mildly worsened," about 17% "moderately worsened," and none "markedly worsened." Regarding physical limitations at 12 months, 7 participants were recorded as improved on the NYHA scale, 20 were unchanged, and 4 had worsened. At 60 months, 8 were recorded as improved, 3 unchanged, and 1 worsened. For the six-minute walk test at 12 months, the average distance walked at the start of the study was reported as approximately 364 metres, and the average change from that starting point at 12 months was a decrease of about 11 metres. No six-minute walk test data at 60 months was 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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• NCT02509156 · results posted 5 November 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02509156) looked at a treatment called Allo-MSCs (donor-derived stem cells) compared to a placebo (an inactive substance) in people with heart failure. The trial had two stages: an open-label lead-in phase, where 6 people received the stem cell treatment with no placebo comparison, and a randomised phase, where participants were randomly assigned to either the stem cell group (14 people) or the placebo group (17 people). In the randomised phase, 12 of the 14 in the stem cell group and 16 of the 17 in the placebo group completed the study. The reported data shows that the trial tracked several primary outcomes. For serious heart-related events (called Major Adverse Cardiac Events — meaning death, hospitalisation for worsening heart failure, or other heart failure episodes), 3 events were recorded in the stem cell group and 6 in the placebo group. For other significant medical events (such as stroke, heart attack, or abnormal heart rhythms), 0 were recorded in the stem cell group and 1 in the placebo group. The reported data also shows that no participants in either group were unable to receive their assigned treatment, and all participants successfully received either the full stem cell dose or placebo as planned. One participant in the stem cell group received fewer than the target number of injections during the procedure, while none in the placebo group did. Regarding heart MRI scans that could not be properly read, 1 participant in the stem cell group and 4 in the placebo group had at least one scan that was uninterpretable. It is important to note that this was a relatively small trial, and the numbers reported here reflect counts of recorded events rather than conclusions about whether the treatment produced any particular benefit or harm. No secondary outcome data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02892448 · results posted 24 August 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people across three groups: 12 who had a single (unilateral) metal-on-metal hip resurfacing implant, 12 who had both hips resurfaced with metal-on-metal implants, and 11 who had a non-metal-on-metal total hip replacement. The trial was measuring heart function using a specialised type of MRI scan, to see whether metal hip implants — which can release tiny amounts of metal particles into the body — were associated with any differences in how the heart looks and works compared to non-metal implants. Of the 35 who started, 30 completed the study (10 in each group). The reported data shows that the primary measurements — which looked at how well the heart pumps (called ejection fraction, measured as a percentage), the volumes of blood moving through the heart's chambers, and two types of MRI signal readings (called T1 and T2\* mapping, which give information about the heart's tissue) — were broadly similar across all three groups. For example, ejection fraction readings ranged from 62–66% across the groups at different time points, and the MRI tissue signal readings (T1 and T2\* times, measured in milliseconds) were also in a comparable range between groups. The reported data shows that for the secondary outcome — the level of cobalt and chromium metals measured in the blood — the bilateral (both hips) metal resurfacing group had the highest reported average levels (cobalt: 2.58 µg/L; chromium: 1.47 µg/L), the single hip resurfacing group had intermediate levels (cobalt: 1.41 µg/L; chromium: 0.71 µg/L), and the non-metal implant group had the lowest levels (cobalt: 0.11 µg/L; chromium: 0.18 µg/L). It is worth noting that this was a small study with only around 10–12 people per group, and no statistical analysis results (such as whether differences between groups were considered meaningful) were included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00883415 · results posted 21 May 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT00883415) enrolled 20 participants in a single group, with 18 completing the study and 2 not completing it. There was no comparison group — all participants received the same intervention, and measurements were taken before treatment began and again six months after starting anaemia (low red blood cell) therapy. The main thing the trial was looking at was whether the heart's uptake of glucose (sugar used for energy) changed over that period, measured using a special imaging scan called a PET scan. The reported data shows that the primary outcome — the change in how much glucose the heart muscle was taking up — was measured in units called micromol/min/100g (a way of expressing how much glucose the heart uses per minute per 100 grams of heart tissue). According to the results reported on ClinicalTrials.gov, the reported change from before treatment to six months after starting anaemia therapy was 4.49 micromol/min/100g. No additional breakdown of secondary outcome measures appears to have been submitted in the structured results data, 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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• NCT02164721 · results posted 4 March 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants, all of whom received a type of heart device called a CRT-D (a combined cardiac resynchronisation therapy and defibrillator device). All 30 participants completed the study. The trial was measuring changes in heart function over six months, focusing mainly on how well the heart's main pumping chamber was working — measured by a figure called the left ventricular ejection fraction (LVEF), which is a percentage that indicates how much blood the heart pumps out with each beat. The reported data shows that, on average, participants' LVEF increased by 10.6 percentage points over the six months. Two measurements of heart chamber size — the volume of the main pumping chamber when it was full (end diastole) and when it had just pumped (end systole) — were reported to have decreased by 31.9 ml and 37.0 ml respectively, meaning the chamber appeared smaller at both points in the pumping cycle. The reported data also shows that the size of the heart's upper-left chamber (left atrium) decreased by an average of 12.6 ml over the same period. Twelve of the 30 participants were reported to have moved into a less severe category on a standard scale used to describe heart failure symptoms (the New York Heart Association functional class). Zero participants died during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02933034 · results posted 17 February 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 33 people with coronary (heart) disease. Of those, 24 completed the study by receiving both types of heart scans being compared. The trial was comparing two different MRI scanning techniques — one using a manganese-based contrast agent (MEMRI) and one using a gadolinium-based contrast agent (DEMRI) — to see how each measured the size of damaged tissue in the heart after a heart attack. The secondary measurements tracked participants' blood pressure, heart rate, and certain electrical signals from the heart during the MEMRI scan. The reported data shows that when using the MEMRI scan, the damaged heart tissue (the core of the injury) measured an average of 12.2% of the left ventricle (the heart's main pumping chamber). The DEMRI scan, which also captures surrounding scar-like tissue, measured an average of 18.9% of the left ventricle. Regarding the secondary measurements taken during the MEMRI scan, systolic blood pressure (the top number in a blood pressure reading) was reported at three time points: 121.8, 160.9, and 124.4 mmHg. Diastolic blood pressure (the bottom number) was recorded as 71.8, 92.6, and 66.2 mmHg. Heart rate was reported as 66.3, 82.8, and 66.2 beats per minute across those same time points. The reported data also shows two measures of heart electrical activity — the QT interval and the corrected QT interval (QTc, which adjusts for heart rate) — recorded at two time points each. QT interval readings were 414.7 and 412.6 milliseconds, while QTc readings were 435.7 and 440.5 milliseconds. The trial noted a normal reference range of 360–450 milliseconds for both measures. It is worth noting that the data as submitted does not specify exactly when during the scan each time point was recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01069510 · results posted 21 August 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people in total — 8 in the placebo group and 7 in the spironolactone group. All 15 participants completed the study. The trial was measuring changes in heart tissue composition using a special type of MRI scan, as well as how far participants could walk in six minutes and levels of a protein in the blood linked to tissue changes in the heart. The reported data shows that the main measurement — called extracellular volume fraction, which is essentially the proportion of heart muscle made up of fluid-filled space rather than muscle cells, measured by MRI — was 30.1% in the placebo group and 25.3% in the spironolactone group. For the six-minute walk test, the placebo group walked an average of 516 metres and the spironolactone group walked an average of 492 metres. For the blood protein measure (Procollagen 3 NT Peptide, a marker related to tissue changes), the reported data shows a level of 3 mcg/l in the placebo group and 4.8 mcg/l in the spironolactone group. It is worth noting that this was a very small trial with only 15 participants, and the results are descriptive numbers only — no further statistical detail (such as whether differences between groups were considered meaningful by the researchers) was included in the data reported 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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• NCT00574119 · results posted 18 June 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 16 people who were given spironolactone, a medication sometimes used for heart conditions. Of those 16, 12 completed the study, while 4 did not finish. The trial was measuring several aspects of how the heart functions, including how efficiently the heart muscle uses energy (called the Work-Metabolic Index, or WMI), how well blood flows through the heart muscle (called the Myocardial Perfusion Reserve Index, or MPRI), changes in heart tissue stiffness or scarring (measured using an MRI scan technique called T1 time), and how far participants could walk in six minutes. The reported data shows that the WMI — a measure of how efficiently the heart is working relative to the energy it uses — was recorded at 7.4 (in the study's units) at the start of the trial, and 5.4 at the six-month mark. For blood flow through the heart muscle, the MPRI was 1.72 at the start and 1.80 at six months. The reported change in heart tissue stiffness (T1 time, linked to scarring in the heart) was 6 milliseconds over the study period. At the start of the trial, participants walked an average of 521 metres in the six-minute walk test; the reported data does not include a six-month result for this measure, so that figure 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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• NCT03212326 · results posted 31 May 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, all of whom received a substance called Definity (an ultrasound contrast agent used to improve the clarity of heart imaging). The trial was looking at whether certain heart imaging techniques — specifically an ultrasound scan of the heart (echocardiography) and electrical mapping of the heart — could identify areas of scarring in the heart muscle, and whether an abnormal heart rhythm called ventricular tachycardia (a fast, potentially dangerous heartbeat starting in the lower chambers of the heart) could be detected and mapped during the procedure. Twenty participants completed the trial, and four did not complete it. The reported data shows that out of the 20 participants who completed the study, all 20 had heart muscle scarring identified on both the ultrasound imaging and the electrical maps. Additionally, the reported data shows that ventricular tachycardia was successfully induced and mapped in all 20 of those participants. It is worth noting that the trial reported results only for the 20 who completed the study, and no separate figures were provided for the four who did not complete it. No data on side effects or safety outcomes was included in the structured results submitted to ClinicalTrials.gov for this trial, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02111993 · results posted 22 May 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 30 in each of two groups. One group underwent standard defibrillation testing (called DFT), which involves deliberately triggering a dangerous heart rhythm to check that an implanted heart device can correct it. The other group underwent an alternative testing method called Upper Limit of Vulnerability (ULV) testing, which aims to assess the device without necessarily triggering that dangerous rhythm. The trial was measuring whether either approach caused detectable heart muscle stress, using a blood marker called cardiac troponin (a protein released into the blood when heart muscle cells are under stress or damaged). Blood samples were taken before testing and again at 4, 8, and 20 hours afterwards. Of the 60 people who started, 25 in the standard testing group and 26 in the ULV group completed the trial. The reported data shows that troponin levels (measured in ng/mL — nanograms per millilitre, a very small unit of measurement) were recorded across both groups at each time point. In the standard defibrillation group, the reported troponin values were 0.001, 0.002, and 0.002 ng/mL at the three time points after testing. In the overall ULV group, the reported values were 0.011, 0.012, and 0.001 ng/mL. The trial also looked separately at people in the ULV group whose dangerous heart rhythm *was* triggered during testing: their reported troponin values were notably higher at 0.075, 0.078, and 0.042 ng/mL. For those in the ULV group whose dangerous rhythm was *not* triggered, the reported values were 0.031, 0.038, and 0.031 ng/mL. The data does not include information about what troponin levels were before testing began, so no before-and-after comparison figures were 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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• NCT01127061 · results posted 15 February 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01127061) enrolled 136 people — 67 in an exercise training group and 69 in a usual activity (no structured exercise) group. The study ran for four months and was measuring several things in people with a heart condition called hypertrophic cardiomyopathy, including how well their hearts and lungs performed during exercise, their quality of life, a heart-stress marker in their blood (called BNP), heart scarring seen on MRI scans, and how well the heart's pumping chamber was working. The reported data shows that for the main outcome — a measure of how much oxygen the body can use during peak exercise (called peak VO2, measured in millilitres per kilogram per minute) — the exercise training group showed an average change of +1.35 units, while the usual activity group showed an average change of +0.08 units. For the additional outcomes, the reported data shows: on a quality-of-life heart failure questionnaire (where lower scores mean better quality of life), the exercise group changed by −5.7 points and the usual activity group by +2.5 points; a depression questionnaire showed changes of −0.1 and +0.04 respectively; and a general health survey showed changes of −1.1 and +2.2 respectively (on this survey, lower scores indicate more difficulty). For the blood marker BNP, the exercise group changed by +5 pg/mL and the usual activity group by +9 pg/mL. Heart scarring (scar volume on MRI) changed by +0.35 grams in the exercise group and −0.03 grams in the usual activity group. The measure of the heart's pumping ability (ejection fraction) changed by −0.2 percentage points in both groups. Measures of a blockage in blood flow out of the heart showed mixed changes across rest, Valsalva manoeuvre, and post-exercise conditions 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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• NCT01983293 · results posted 2 January 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01983293) involved 242 participants in total — 161 in the "QLV" group (a heart device implant approach guided by a specific electrical timing measurement) and 81 in the "Standard of Care" group (the usual implant approach). The trial was looking at people with a particular heart condition and comparing these two approaches over 12 months. It measured outcomes using something called a Clinical Composite Score, which combined four things: how much symptoms affected daily life (graded by a doctor), how the patient felt overall, whether they had any heart failure events, and whether they died from a heart-related cause. Based on these four things together, each participant was classed as "improved," "worsened," or "unchanged" at 12 months. The reported data shows that, of those who completed the study, 86 out of 128 participants in the QLV group were classed as "improved" at 12 months. In the Standard of Care group, 45 out of 62 completers were classed as "improved." The data as submitted does not separately report how many in each group were classed as "worsened" or "unchanged," so those figures cannot be described here. It is also worth noting that 33 participants in the QLV group and 19 in the Standard of Care group did not complete the study, though the reasons for this were not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02292186 · results posted 15 June 2018

  According to the results reported on ClinicalTrials.gov, this trial looked at a drug called revusiran (also known as ALN-TTRSC) in people with a heart condition called TTR cardiac amyloidosis — a disease where an abnormal protein called transthyretin builds up in the heart. A total of 25 people took part in the single treatment group. The trial was measuring how the drug affected participants over the long term, including any unwanted effects, changes in TTR protein levels in the blood, deaths, hospital admissions, and how far participants could walk in six minutes. The reported data shows that of the 25 participants who started the trial, 7 completed it and 18 did not finish. When it came to unwanted effects, 25 participants experienced adverse events (any unexpected or undesirable experience during the study), 22 experienced serious adverse events (more significant or life-threatening experiences), and 18 stopped taking the study drug. Regarding deaths, 8 participants died during the study, and of those, 6 deaths were assessed by an independent review committee as being related to cardiovascular (heart and blood vessel) causes. For hospital admissions, 17 participants were hospitalised at some point, with 15 of those admissions judged to be cardiovascular-related. The six-minute walk test — which measures how far someone can walk in six minutes — showed an average change of minus 20.6 metres from the start of the study to one point in time, and minus 104.6 metres at another point, meaning participants were on average walking shorter distances compared to when they started. The data on TTR blood protein levels was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02291237 · results posted 22 March 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02291237) enrolled 172 people with heart failure — 86 who received the investigational drug eleclazine and 86 who received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether eleclazine made any difference to participants' ability to exercise, their quality of life, and how long they could walk on a treadmill. The reported data shows that none of the 172 participants were recorded as having "completed" the study in the formal sense, meaning all participants were counted under "not completed" — this may reflect how the trial was structured or stopped, though no further explanation was provided in the submitted data. The reported data shows that the main thing being measured was the change in peak oxygen uptake during an exercise test (a measure of how much oxygen the body can use during peak effort, expressed in millilitres per kilogram per minute) from the start of the trial to week 24. In the eleclazine group, this figure changed by an average of +0.15 mL/kg/min, while in the placebo group it changed by +0.48 mL/kg/min. At the 12-week mark, the reported changes were +0.28 for eleclazine and +0.57 for placebo. For the quality-of-life questionnaire (scored 0–105, where lower means better), both groups started with similar scores (around 40), and by week 24 the eleclazine group's score had changed by −4.05 points and the placebo group's by −5.57 points; at week 12 the changes were −3.84 and −3.40 respectively. For treadmill exercise time, both groups started at roughly similar levels, and by week 24 the eleclazine group's time changed by +0.27 minutes and the placebo group's by +0.24 minutes; at week 12 the changes were +0.48 and +0.38 minutes 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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• NCT02170363 · results posted 15 February 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people who received a heart assist device called the HeartMate 3 — a mechanical pump implanted to help a failing heart move blood around the body. All 50 participants completed the study. The main thing the trial was measuring was whether participants were still alive at six months. It also tracked quality of life, how far participants could walk in six minutes, how much their heart symptoms limited daily activities, and how often unwanted medical events or device problems occurred. The reported data shows that 92% of participants were alive at six months. For quality of life, participants rated their own health on a scale from 0 (worst imaginable) to 100 (best imaginable); scores were reported at four time points — baseline, one month, three months, and six months — as 50, 60, 70, and 75 respectively, suggesting the scores rose over time. The six-minute walk test (measuring how far someone can walk in six minutes) recorded distances of 236 metres, 260 metres, 375 metres, and 385 metres at those same four time points. Regarding daily activity limitations, at baseline all participants fell into the more severe symptom categories; by six months, the reported data shows 83% were in a category with only slight limitations and 17% remained in a category with more marked limitations. For unwanted medical events, various pre-defined events were tracked and reported across a range of 0% to 38% of participants depending on the specific event type. Three device controller alarms and 14 instances of low-flow warnings were also recorded, with no reports of pump malfunctions. 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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• NCT03225001 · results posted 9 January 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT03225001) enrolled 197 participants, all of whom had a previously implanted surgical heart valve that was no longer working properly. The trial was testing the Edwards SAPIEN XT, a type of replacement heart valve inserted without open-heart surgery (known as a "valve-in-valve" procedure). Of the 197 people who started, 195 had the valve successfully placed, and 188 completed the study, with 9 not completing it for reasons not detailed here. The reported data shows that the main (primary) outcome was a combined measure tracking how many participants experienced any of four events: death from any cause, any stroke, a significant blockage of the new valve, or a significant leak around the new valve. According to the results reported on ClinicalTrials.gov, 28 out of 195 participants who received the valve experienced at least one of these four events. For the secondary outcome — death from any cause (including heart-related causes) — the reported data shows that 8 participants died during the study period. It is worth noting that the data submitted does not include timeframes for when these events were measured, so it is not possible to say over what period these numbers were recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00585546 · results posted 15 December 2017

  According to the results reported on ClinicalTrials.gov, 18 people with serious heart failure were enrolled in this trial. They all received a mechanical heart pump called an LVAD (a device implanted to help a weakened heart pump blood), and those whose hearts showed enough recovery after four months were then given a drug called clenbuterol, which was intended to help the heart muscle strengthen further. The trial was primarily measuring how many participants were able to have their LVAD removed and then remain free from another heart pump or a heart transplant for at least one year afterwards. The reported data shows that of the 18 people who started, 13 completed the pump-support phase and moved on to receive clenbuterol. Of those 13, all received the maximum target dose of clenbuterol. When it came to the main outcome, only 1 participant out of the original 18 met the criteria to have their LVAD removed — and that person had the device removed approximately 28 weeks after it was first implanted. This translated to a reported figure of 5.6% of all participants achieving the primary goal of living without a pump or transplant for one year after removal. For that one participant, a measure of how well the heart was pumping (called ejection fraction, a percentage reflecting the heart's pumping strength) was reported to have changed by −0.09 units between the time of device removal and 18 months later. The reported data also shows that two blood markers — creatinine (a kidney-related marker) and AST (a liver-related marker) — changed by approximately 17.2% and 25% respectively from the start of the trial to eight weeks after the pump was implanted, though the data does not specify the direction of those changes. It is worth noting that 5 of the original 18 participants did not complete the pump phase, and a further 4 did not complete the clenbuterol phase; the reasons for not completing 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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• NCT01798992 · results posted 20 February 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 56 people across four groups. Four participants served as a "non-failing control" group (people without heart failure, used for comparison purposes only). The remaining 52 participants had heart failure and were each given one of three different heart medications: metoprolol succinate alone (19 people), metoprolol succinate combined with doxazosin (16 people), or carvedilol (17 people). The trial was primarily looking at whether a specific heart pump measurement — called Left Ventricular Ejection Fraction, or LVEF, which is simply a measure of how well the heart is pumping blood — improved over 12 months of treatment. The reported data shows that, at the 12-month mark, 12 out of 19 participants in the metoprolol succinate group, 10 out of 16 in the metoprolol succinate plus doxazosin group, and 9 out of 17 in the carvedilol group met the trial's definition of an improvement in heart pumping function. At the earlier 3-month check, the reported numbers were 16, 10, and 10 participants respectively across those same three groups. For a separate secondary measure tracking serious events over 18 months — specifically death from any cause, the need for a heart transplant, or the need for a mechanical heart-assist device — the reported data shows 1 participant in the metoprolol succinate group experienced one of these outcomes, while no participants in the other two treatment groups did. Some additional gene expression measurements were planned but their results were not included in the ClinicalTrials.gov data submission and were instead reported elsewhere. 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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• NCT01721967 · results posted 18 January 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 14 people, all of whom received the medication ranolazine. The trial was looking at a heart condition called hypertrophic cardiomyopathy (HCM), and it was measuring things like a specific heart rhythm reading (called the QT interval, which reflects the timing of the heart's electrical activity), how well participants tolerated the medication, and whether certain symptoms — like chest pain episodes — changed over time. Eleven of the 14 participants completed the trial, and three did not finish. The reported data shows that the average QT interval measurement across participants was 462.8 milliseconds. In terms of tolerability, the reported data shows that 9 participants tolerated the higher dose of 1,000 mg twice daily, while 4 participants tolerated the lower dose of 500 mg twice daily. There were 10 adverse events (unwanted health occurrences) recorded that were considered possibly or probably related to the study drug. Two quality-of-life questionnaires — the Seattle Angina Questionnaire and the Kansas City Cardiomyopathy Questionnaire — were also completed, with scores reported across several categories on a scale of 0 to 100 (where higher scores represent better quality of life). The Seattle Angina Questionnaire scores across its five areas ranged from 61.4 to 90.6, and the Kansas City Cardiomyopathy Questionnaire scores across its categories ranged from 65.2 to 85.2. The data for the number of chest pain episodes per week was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01048125 · results posted 23 November 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01048125) involved two groups — a Study Group and a Control group — and was looking at stress cardiomyopathy, a condition where the heart temporarily weakens, often triggered by intense physical or emotional stress. The trial aimed to identify risk factors and develop strategies that might prevent this condition in people who could be particularly vulnerable to it. The reported data shows that the participant numbers recorded for both groups were zero — meaning no participants were listed as having started, completed, or withdrawn from the trial. This suggests the trial did not enrol any participants, though the reasons for this are not explained in the submitted data. The reported data also shows that no measurements were submitted for the primary outcome measure, so there are no numerical findings to describe. It is not possible to draw any conclusions about the research question from the information provided on ClinicalTrials.gov, as the data 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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• NCT00624520 · results posted 22 December 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 103 people in total — 56 in a group that received Cognitive Behavioural Stress Management (a structured program teaching stress-coping skills) and 47 in a Patient Education group. Of those, 44 and 39 people respectively completed the trial. The trial was measuring how the two approaches compared on a range of heart and psychological stress responses, particularly the body's reaction during a mental stress task (doing mental arithmetic). The reported data shows that the main (primary) outcome was a measure called "double product" — a combined calculation of heart rate and blood pressure that rises when the body is under stress, where a higher number means a bigger stress response. At the time point the results table captures, the Cognitive Behavioural Stress Management group recorded a double product elevation of 1,399 units and the Patient Education group recorded 1,063 units; at another recorded time point the figures were 1,514 and 1,538 respectively. (Note: the data as submitted includes three sets of measurements per group but does not clearly label which time point each set belongs to, so the full picture of change over time cannot be described here.) For the secondary outcomes — self-reported questionnaire scores measuring anger, anxiety/tension, perceived stress, depression, and a heart-rhythm measure called low-frequency heart rate variability — the reported data shows the Cognitive Behavioural Stress Management group scored 16, 8, 10, 20, and 59 respectively, while the Patient Education group scored 19, 12, 14, 24, and 70. On all of these scales, lower scores represent a less severe result. 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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• NCT00376532 · results posted 4 June 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 63 people in total — 31 in a group who had experienced an event triggered by their implantable cardioverter-defibrillator (ICD, a small device implanted in the chest to monitor and respond to dangerous heart rhythms), and 32 in a group who had not experienced such an event. Of those, 25 and 26 people respectively completed the study, with 6 people in each group not completing it. The trial was measuring blood levels of two proteins — called MMP-2 and MMP-9 — to see whether those levels differed between people who had an ICD event and those who had not. The reported data shows the following average blood protein levels (measured in picograms per millilitre, a very small unit of concentration): For MMP-2, the group who had an ICD event had a reported average level of 173,493 pg/ml, compared with 139,012 pg/ml in the group who had no ICD event. For MMP-9, the group who had an ICD event had a reported average level of 1,033,546 pg/ml, compared with 680,389 pg/ml in the group who had no ICD event. No other outcome measures were reported in the submitted data beyond these two protein measurements. It is worth noting that the results as submitted do not include additional statistical detail — such as measures of variability or whether the differences between groups were considered statistically meaningful — so those figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02115581 · results posted 16 April 2014

  According to the results reported on ClinicalTrials.gov, this trial involved 38 children in total — 17 who received Coenzyme Q10 (a dietary supplement) and 21 who received a placebo (a dummy treatment with no active ingredient). All 38 participants completed the study, with no dropouts recorded. The trial was measuring two things related to heart function: how well the heart's main pumping chamber (the left ventricle) was pumping blood out with each beat, and whether the way the heart was filling with blood between beats improved over the course of the study. The reported data shows that, at the end of the study, the Coenzyme Q10 group had an average "ejection fraction" — meaning the percentage of blood pumped out of the left ventricle with each heartbeat — of 42.1%, compared with 37.6% in the placebo group. For the second heart function measure (how well the heart fills with blood between beats), the reported data shows that 59% of participants in the Coenzyme Q10 group showed an improvement in their grading, compared with 19% in the placebo group. Regarding side effects such as nausea, vomiting, blood pressure changes, or unusual behaviour, the reported data shows that zero participants in either group experienced any of these monitored reactions. 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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• NCT00358215 · results posted 13 December 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 2,278 people with heart failure — 1,142 in the placebo group and 1,136 in the darbepoetin alfa (a medication used to stimulate red blood cell production) group. The trial was measuring whether darbepoetin alfa made a difference to how long it took for participants to either die from any cause or be admitted to hospital for worsening heart failure. Roughly 1,100 people in each group did not complete the study, for various reasons. The reported data shows that the primary outcome — the estimated midpoint time (meaning the point by which half of participants had experienced the event) before either dying or being hospitalised for worsening heart failure — was 1,260 days in the placebo group and 1,184 days in the darbepoetin alfa group. For death from any cause alone, the reported figures were 1,637 days for placebo and 1,629 days for darbepoetin alfa. For the combined measure of cardiovascular death or first hospitalisation for worsening heart failure, the reported figures were 1,414 days for placebo and 1,395 days for darbepoetin alfa. The trial also used a heart failure quality-of-life questionnaire (scored 0–100, where higher scores mean better wellbeing). The reported average improvement from the start of the study to six months was 4.48 points for placebo and 6.68 points for darbepoetin alfa on the overall summary score, and 3.91 versus 6.20 points on the symptom frequency score. 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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• NCT00121485 · results posted 29 October 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 200 people with severe heart failure who could not yet receive a heart transplant. Participants were assigned to receive one of two mechanical heart pump devices — 134 received the HeartMate II (a newer, continuous-flow pump) and 66 received the HeartMate XVE (an older, pulsatile-flow pump). The trial's main goal was to measure how many people in each group were still alive after two years, without having had a stroke or needing surgery to fix or replace their device. The reported data shows that for the primary (main) measure, 46% of HeartMate II recipients and 11% of HeartMate XVE recipients met this combined goal at two years. Several secondary (additional) measures were also tracked over time. Quality-of-life questionnaires — the Minnesota Living With Heart Failure (scored 0–105, where lower is better) and the Kansas City Cardiomyopathy Questionnaire (scored 0–100, where higher is better) — were completed at baseline and at 1, 3, 6, and 12 months. The reported data shows scores moved in a direction suggesting improvement in both groups across those time points, though exact figures at each time point were included in the submission. A six-minute walking test was also reported, with both groups recording greater distances walked at later time points compared to the start — for example, HeartMate II participants went from a reported average of 182.5 metres at baseline to 377.2 metres at six months. Ratings of physical limitation (NYHA classification) and a patient activity score were also measured, with the reported numbers suggesting shifts toward lower limitation categories over time 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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• NCT00273182 · results posted 5 August 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,999 people, all grouped together as a single study group. It was designed to track what happened to participants over three years after they had a heart device implanted — specifically a lead (a thin wire) connected to the left ventricle (the heart's main pumping chamber). The trial measured death rates over that period, as well as how the device lead performed technically over time and whether it caused any complications requiring further medical intervention. The reported data shows that, of the 1,999 people who started the study, 1,014 completed it and 985 did not complete it (the reasons were not broken down further in the data provided here). For the primary outcome — deaths over three years — the data shows 450 deaths recorded overall and 213 deaths attributed to heart-related causes specifically; the full survival analysis used a statistical method called Kaplan-Meier estimates (a way of tracking how many people were still alive at each point in time), but the detailed curves were reported separately in the statistical analysis section rather than here. For the device lead's technical performance, the reported average electrical signal detected by the lead (R-wave amplitude) ranged from about 13.2 to 13.7 millivolts across the six measurement time points, the electrical resistance of the lead (impedance) ranged from roughly 620 to 633 ohms, and the voltage needed to make the lead pace (stimulate) the heart ranged from about 1.65 to 1.76 volts across follow-up visits. The reported data also shows that 176 participants experienced a complication directly related to the left ventricular lead that required invasive treatment or caused a significant loss of device function. 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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• NCT00608140 · results posted 18 July 2013

  According to the results reported on ClinicalTrials.gov, this trial was set up to compare two approaches for people with heart failure and a leaky heart valve (mitral valve): one group would receive standard medical treatment plus surgery to repair the mitral valve, while the other group would receive standard medical treatment alone. The main thing the trial aimed to measure was whether adding surgery caused a change in the size of the heart's left pumping chamber over time — a process called "remodelling." Several other things were also planned to be measured, including exercise capacity, how far participants could walk in six minutes, quality of life, days spent out of hospital, and overall survival at 18 months. The reported data shows that only two people were enrolled in total — one in each group — and neither participant completed the trial. The trial was terminated early, and because neither participant reached the planned 18-month follow-up point before the trial ended, no measurements were collected and no analysis was performed for any of the planned outcomes, whether primary or secondary. The ClinicalTrials.gov record contains no numerical results for any of the measures. The reported data shows that, due to the trial being stopped with only two participants enrolled, there is simply no outcome data available from this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01478087 · results posted 11 February 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT01478087) enrolled 3 participants, all of whom were in a single group receiving a treatment referred to as "IA Treatment." The trial was measuring how often serious adverse events — that is, significant harmful incidents — occurred within 30 days after the procedure, looking separately at whether any such events were related to the procedure itself or to the device used. The reported data shows that 2 of the 3 participants completed the study, while 1 did not complete it (the reason was not reported in the data provided). For both primary outcome measures — the rate of serious adverse events linked to the procedure and the rate of serious adverse events linked to the device — the reported figure was 0%, meaning no such events were recorded among the participants during the 30-day follow-up period. No secondary outcome data appears to have been reported in the structured results. It is worth noting that with only 3 participants, this was a very small study, and the reported data does not include any other outcome measures beyond these two figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00252187 · results posted 20 December 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people in total — 24 in the B-type Natriuretic Peptide (BNP) group and 21 in the placebo group. By the end of the study, 20 people in each group had completed it. The trial was measuring changes in heart structure and function over 8 weeks, specifically looking at the size and mass of the left ventricle (the heart's main pumping chamber), as well as kidney function, heart filling pressure, and other related measures. Participants received either BNP or a placebo (an inactive treatment used for comparison). The reported data shows the following changes from the start of the trial to 8 weeks. For the primary outcomes, the BNP group showed a reported change in left ventricular volume index (a measure of the heart chamber's size relative to body size) of −5.2 and −10.0 ml/m² (two separate volume measures), while the placebo group showed changes of +5.8 and +6.1 ml/m². For left ventricular mass index (a measure of the heart muscle's weight relative to body size), the BNP group showed a change of −4.4 mg/m², compared with +6.2 mg/m² in the placebo group. For the secondary outcomes, the BNP group showed a change in heart filling pressure of −2.3 (compared with +1.1 in the placebo group), a change in plasma renin activity (a substance in the blood linked to blood vessel tightening) of −3.5 (compared with +2.3 in the placebo group), and a change in kidney filtration rate of +6.9 ml/min/1.73 m² (compared with −2.8 in the placebo group). Heart rate changed by −1.6 beats per minute in the BNP group and −0.9 beats per minute 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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• NCT00180323 · results posted 12 November 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 43 participants, all of whom completed the study with no drop-outs. The trial involved people who had received a type of heart device called a Cardiac Resynchronization Therapy ICD (a device implanted in the chest to help coordinate the heartbeat). The study was measuring how well the device could be fine-tuned over time, specifically looking at two main things: how blood flows out of the heart (called Aortic Velocity Time Integral, measured in centimetres), and the timing setting between the heart's upper and lower chambers (called AV-Delay, measured in milliseconds). Measurements were taken at the time of implant, and again at 3 and 6 months, at different heart rates. The reported data shows that the blood flow measurements (Aortic VTI) ranged across the various heart rate and time-point combinations, with values spanning roughly 18.1 cm to 24.6 cm across all recorded readings. The AV-Delay timing settings ranged from approximately 115 milliseconds to 132 milliseconds across the different time points and heart rates tested. For the secondary measures, the reported data shows that the distance participants walked in 6 minutes was 388 metres at the start of the study, rising to 470 metres at 3 months and 497 metres at 6 months. The reported measure of how much blood the heart pumps out with each beat (Left Ventricular Ejection Fraction, expressed as a percentage) was 21% at the start, and 24% at both the 3-month and 6-month follow-up 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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• NCT01223703 · results posted 25 July 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 133 people in total — 67 in the omega-3 fatty acids (n-3 PUFAs) group and 66 in the placebo group. All participants completed the study with no drop-outs recorded. The trial was measuring changes in heart function over 12 months, specifically how well the heart pumps blood (called the left ventricular ejection fraction, or LVEF — a percentage that reflects how much blood the heart squeezes out with each beat), as well as secondary measures including how the heart fills between beats, exercise capacity, and participants' self-reported symptom class. The reported data shows that for the primary measure — heart pumping function (LVEF) — the omega-3 group started at an average of 36% and finished at 39%, while the placebo group started at 37% and finished at 35%. For the secondary measure of heart-filling function (reported as an E/A ratio, a value derived from ultrasound of blood flowing into the heart), the omega-3 group went from 0.89 to 0.84, and the placebo group went from 0.90 to 0.98. For exercise capacity (peak oxygen uptake, a measure of how much oxygen the body uses during peak effort), the omega-3 group went from 19.5 to 20.7 ml/kg/min, while the placebo group went from 18.3 to 17.4 ml/kg/min. Finally, for symptom class (rated 1–4, where lower numbers mean fewer limitations), the omega-3 group went from an average of 2.21 to 1.91, and the placebo group went from 2.17 to 2.32. No data was reported on whether any of these differences between groups were statistically meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00682565 · results posted 25 February 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 95 people in total — 31 in the mid-dose active drug group, 35 in the high-dose active drug group, and 29 in the placebo (inactive treatment) group. The trial was testing a drug called CK-1827452, given through a drip over 20 hours, in people with a heart condition called angina (chest pain during physical effort). The main thing being measured was whether participants stopped a treadmill walking test — done near the end of the infusion — at an earlier point than they had during a baseline treadmill test done before the drug was given, specifically because of chest pain. The reported data shows that for the primary measure — stopping the treadmill test earlier due to chest pain — 0 participants in either active drug group stopped earlier than their baseline test, compared to 1 participant in the placebo group. For the secondary measures, 4 mid-dose and 2 high-dose participants stopped the treadmill test earlier than baseline for any reason, compared to 1 in the placebo group. When looking at how much longer participants could exercise during the treadmill test compared to their baseline, the reported data shows increases of 41.5 seconds (mid-dose), 40.5 seconds (high-dose), and 60.1 seconds (placebo). The number of participants who stopped the treadmill test due to chest pain at any point was 0 in the mid-dose group, 7 in the high-dose group, and 2 in the placebo group. Finally, 0 mid-dose, 1 high-dose, and 2 placebo participants showed a particular change in their heart trace (a 1 mm dip in a reading called the ST segment) during the treadmill test. 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.