Trial · NCT03496168
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events | From first dose to end of treatment + 56 days (Approximately an average of 240 Weeks) | AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: * Results in death * Is immediately life-threatening (places the participant at immediate risk of death from the event as it occurred) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions * Results in a congenital abnormality or birth defect * Is an important medical event that may not result in death, be life- threatening, or require hospitalization, but may be considered an SAE when, based upon appropriate medical judgment, it may require medical or surgical intervention to prevent any of the outcomes listed above. |
| Primary | Number of Participants Who Had Cardiovascular Death | From first dose to end of study, (approximately 260 weeks) | Number of participants who had died due to cardiovascular reasons. |
| Primary | Number of Participants Who Experienced Sudden Death | From first dose to end of study, (approximately 260 weeks) | Number of participants who experienced sudden death |
| Primary | Number of Participants Who Were Hospitalized for Cardiovascular Reasons. | From first dose to end of study, (approximately 260 weeks) | Number of participants who were hospitalized for cardiovascular reasons. |
| Primary | Number of Participants With Heart Failure Due to Systolic Dysfunction, Defined as Asymptomatic LVEF < 50% | From first dose to end of study, (approximately 260 weeks) | Number of participants with heart failure due to systolic dysfunction, defined as asymptomatic LVEF \< 50% |
| Primary | Number of Participants With LVEF < 50% as Measured by Echocardiography. | From first dose to end of study, (approximately 260 weeks) | Number of participants with LVEF \< 50% as measured by echocardiography. |
| Primary | Number of Participants Who Were Experienced Myocardial Infarction | From first dose to end of study, (approximately 260 weeks) | Number of participants who experienced myocardial infarction. |
| Primary | Number of Participants With Ventricular Arrhythmias. | From first dose to end of study, (approximately 260 weeks) | Types of Ventricular Arrhythmias measured in this endpoint will be: Ventricular Tachycardia Ventricular Fibrilation Ventricular Flutter |
| Primary | Number of Participants Who Experienced Syncope | From first dose to end of study, (approximately 260 weeks) | Number of participants who experienced syncope. Syncope will be defined as participants who experienced dizziness or orthostatic hypotension. |
| Primary | Number of Participants Who Experienced Seizures | From first dose to end of study, (approximately 260 weeks) | Number of participants who were experienced seizures. |
| Primary | Number of Participants Who Were Experienced Strokes | From first dose to end of study, (approximately 260 weeks) | Number of participants who were experienced strokes. |
| Primary | Number of Participants With a Change in QT and QTcF Intervals. | From first dose to end of study, (approximately 260 weeks) | Number of participants with a change in QTcF intervals. QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR/1000) RR = Respiration rate QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec |
| Primary | Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time | At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252 | Number of participants with changes of Post-exercise left ventricular outflow tract (LVOT) gradient over time |
| Primary | Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time | At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252 | Resting left ventricular outflow tract (LVOT) gradient over time |
| Primary | Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time | At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252 | Post Valsalva left ventricular outflow tract (LVOT) gradient over time |
| Primary | Participants With >= 1 NYHA Function Class Improvement | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 | Participants with \>= 1 NYHA function class improvement. The NYHA Functional Classification of heart failure assigns participants to 1 of 4 categories based on the participant's symptoms. Class 1: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class 2: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class 3: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class 4: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. |
| Primary | Mean Change From Baseline in the Overall KCCQ PRO Score. | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-administered 23-item questionnaire questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. Overall KCCQ Pro score is the average of all the domains, symptom frequency and symptom burden scores, and transformed to a single score which ranged from 0 (worst) to 100 (the best possible status), where the higher score reflected better health status. |
| Primary | Mean Change From Baseline in Serum NT-proBNP. | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 | Mean change from baseline in Serum N-terminal pro B-type natriuretic peptide levels. |
| Primary | Number of Participants Who Received Septal Reduction Therapy | 252 weeks | Number of participants who received septal reduction therapy |
| Primary | Plasma Concentration of Mavacamen Overtime | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 | Plasma concentration of Mavacamen overtime |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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