SYMPTOMATIC NON-OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY
Conditions
Brief summary
Dual primary endpoints of: • Change in KCCQ-CSS from baseline to Week 36 • Change in pVO2 from baseline to Week 36
Detailed description
Proportion of participants with ≥ 1 class improvement in NYHA Functional Class from baseline to Week 36, Change in the composite of two Z-scores of CPET parameters from baseline to Week 36: – pVO2 (maximal exercise capacity) – VE/VCO2 slope (sub-maximal exercise capacity), Change in NT-proBNP from baseline to Week 36, Change in LAVI from baseline to Week 36, Time to first event of cardiovascular death, heart transplantation or left ventricular assist device, aborted sudden cardiac death, non-fatal stroke, heart failure hospitalization, or cardiac arrhythmia (atrial fibrillation or ventricular tachyarrhythmia) requiring treatment or hospitalization
Interventions
Sponsors
Cytokinetics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dual primary endpoints of: • Change in KCCQ-CSS from baseline to Week 36 • Change in pVO2 from baseline to Week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with ≥ 1 class improvement in NYHA Functional Class from baseline to Week 36, Change in the composite of two Z-scores of CPET parameters from baseline to Week 36: – pVO2 (maximal exercise capacity) – VE/VCO2 slope (sub-maximal exercise capacity), Change in NT-proBNP from baseline to Week 36, Change in LAVI from baseline to Week 36, Time to first event of cardiovascular death, heart transplantation or left ventricular assist device, aborted sudden cardiac death, non-fatal stroke, heart failure hospitalization, or cardiac arrhythmia (atrial fibrillation or ventricular tachyarrhythmia) requiring treatment or hospitalization | — |
Countries
Denmark, France, Germany, Greece, Hungary, Iceland, Italy, Netherlands, Poland, Portugal, Spain
Outcome results
None listed