Non-obstructive Hypertrophic Cardiomyopathy
Conditions
Brief summary
Change from baseline in KCCQ CSS at Week 48, Change from baseline in pVO2 at Week 48
Detailed description
Change from baseline in VE/VCO2 slope to Week 48, Proportion of participants with at least 1 class of NYHA improvement from baseline to Week 48, (3.-4.) 3. Change from baseline in NT-pro BNP to Week 48 4. Change from baseline in cTn-T to Week 48, (5.-6.) 5. Change from baseline in HCMSQ-SoB domain to Week 48 6. Time to First MACE-Plus events defined as any CV death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, hospitalization for arrhythmias or appropriate ICD therapy
Interventions
DRUGMavacamten
DRUGMYK-461 Capsules
DRUGPlacebo is a solid oral dosage form in size 2 gelatin capsules each containing 120 mg of an
excipient blend. It is intended as a placebo to match MYK-461 Capsules of all active strengths.
Sponsors
Myokardia Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in KCCQ CSS at Week 48, Change from baseline in pVO2 at Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in VE/VCO2 slope to Week 48, Proportion of participants with at least 1 class of NYHA improvement from baseline to Week 48, (3.-4.) 3. Change from baseline in NT-pro BNP to Week 48 4. Change from baseline in cTn-T to Week 48, (5.-6.) 5. Change from baseline in HCMSQ-SoB domain to Week 48 6. Time to First MACE-Plus events defined as any CV death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, hospitalization for arrhythmias or appropriate ICD therapy | — |
Countries
Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Spain
Outcome results
None listed