Trial · NCT05489705
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 | Incidence rate of new or worsening heart failure due to systolic dysfunction among participants with symptomatic obstructive HCM during periods of exposure to mavacamten and other oHCM treatment | Up to 5 Years | Systolic dysfunction defined as symptomatic Left Ventricular Ejection Fraction (LVEF) \< 50%. United States participants only. |
| Primary | Change in resting left ventricular outflow tract (LVOT) gradient from baseline | Up to 18 months | European Participants only |
| Secondary | Occurrence of arrhythmia | Baseline, and up to 18 months (European participants), or 5 Years (United States participants) | Incidence rates of participants with arrhythmia (new onset) |
| Secondary | New or worsening heart failure due to systolic dysfunction | Baseline and up to 18 months | Symptomatic left ventricular ejection fraction (LVEF) \<50%. European Participants only |
| Secondary | Proportion of participants with a resting or provoked peak left ventricular outflow tract (LVOT) gradient below 50 mmHG | Baseline and up to 18 months | European participants only |
| Secondary | Proportion of participants with a resting or provoked peak left ventricular outflow tract (LVOT) gradient below 30 mmHG | Baseline and up to 18 months | European participants only |
| Secondary | Occurrence of Major Adverse Cardiovascular Events (MACE) | Up to 5 Years | A composite endpoint consisting of non-fatal acute Myocardial Infarction (MI), stroke, hospitalization due to Heart Failure (HF) and Cardiovascular (CV) mortality. United States participants only. |
| Secondary | Occurrence of non-fatal acute Myocardial Infarction (MI) | Up to 5 Years | United States participants only |
| Secondary | Occurrence of Stroke | Up to 5 Years | United States participants only |
| Secondary | Occurrence of hospitalization due to heart failure | Baseline, and up to 18 months (European participants), or 5 Years (United States participants) | |
| Secondary | Occurrence of cardiovascular mortality | Up to 5 Years | United States participants only |
| Secondary | Occurrence of all-cause mortality | Baseline, and up to 18 months (European participants), or 5 Years (United States participants) | |
| Secondary | Evaluation of functional responses: New York Heart Association (NYHA) function class | Baseline, and up to 18 months (European participants), or 5 Years (United States participants) | Percentage of Participants Whose NYHA Class Changes |
| Secondary | Evaluation of functional responses: Left Ventricular Outflow Tract (LVOT) gradient | Baseline, and up to 18 months (European participants), or 5 Years (United States participants) | Mean Change From Baseline in LVOT Gradients At Rest and Provoked |
| Secondary | Evaluation of functional responses: LVEF | Baseline, and up to 18 months (European participants), or 5 Years (United States participants) | Mean Change from Baseline in LVEF |
| Secondary | Evaluation of patient reported outcome measure: Kansas City Cardiomyopathy Questionnaire 23 (KCCQ-23) | Baseline, and up to 5 Years | The KCCQ-23 is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. United States participants only |
| Secondary | Evaluation of patient reported outcome measure: EuroQol Five Dimensions Questionnaire (5-level) (EQ-5D-5L): Health Utility Index | Baseline, and up to 5 Years | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L health utility index and EQ Visual Analog Scale (VAS). EQ-5D-5L health utility index is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participants select an answer for each of the 5 dimensions that best matches his/her health "today". Responses are used to generate a weighted summary index, which ranges from 0 to 1.00. A higher score indicates better health and positive changes from baseline indicate improvement of health. United States participants only |
| Secondary | Evaluation of patient reported outcome measure: EQ-5D-5L: VAS | Baseline, and up to 5 Years | The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and VAS. The VAS self-rating records the participant's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status. United States participants only |
| Secondary | Evaluation of biomarkers of response: NT-proBNP | Baseline, and up to 5 Years | Change From Baseline in Serum concentration of NT-proBNP. United States participants only |
| Secondary | Evaluation of biomarkers of response: Cardiac troponin | Baseline, and up to 5 Years | Change From Baseline in Serum Concentration of Cardiac Troponins. United States participants only |
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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GET https://conductscience.org/api/trials/v1/NCT05489705/registered