Symptomatic Obstructive Hypertrophic Cardiomyopathy
Conditions
Brief summary
Change in peak oxygen uptake (pVO2) by cardiopulmonary exercise testing (CPET) from baseline to Week 24
Detailed description
Proportion of participants with ≥ 1 class improvement in NYHA Functional Class from baseline to Week 24, Change in Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-CSS) from baseline to Week 24, "• Change in left ventricular mass index (LVMI) from baseline to Week 24 • Change in left atrial volume index (LAVI) from baseline to Week 24", Change from baseline values in NT-proBNP from baseline to Week 24, Change in post-Valsalva LVOT-G from baseline to Week 24
Interventions
DRUGPlacebo (Metoprolol succinate)
DRUGMetoprololsuccinat STADA® 47
DRUG5 mg Retardtabletten
DRUGAficamten
DRUGDOBUTAMINE
DRUGPlacebo (Aficamten)
Sponsors
Cytokinetics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peak oxygen uptake (pVO2) by cardiopulmonary exercise testing (CPET) from baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with ≥ 1 class improvement in NYHA Functional Class from baseline to Week 24, Change in Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-CSS) from baseline to Week 24, "• Change in left ventricular mass index (LVMI) from baseline to Week 24 • Change in left atrial volume index (LAVI) from baseline to Week 24", Change from baseline values in NT-proBNP from baseline to Week 24, Change in post-Valsalva LVOT-G from baseline to Week 24 | — |
Countries
Denmark, France, Germany, Hungary, Italy, Netherlands, Spain
Outcome results
None listed