Symptomatic Obstructive Hypertrophic Cardiomyopathy
Conditions
Brief summary
To evaluate the efficacy of mavacamten on both the reduction in heart wall thickness and upper chamber size at week 48 on cardiac magnetic resonance (CMR).
Detailed description
To evaluate the impact of mavacamten treatment: on improvement of heart failure class in symptomatic oHCM (New York Heart Association [NYHA] Functional Class) as well as monitor for other cardiac events as a safety assessment.
Interventions
DRUGMavacamten
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 |
|---|---|
| To evaluate the efficacy of mavacamten on both the reduction in heart wall thickness and upper chamber size at week 48 on cardiac magnetic resonance (CMR). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the impact of mavacamten treatment: on improvement of heart failure class in symptomatic oHCM (New York Heart Association [NYHA] Functional Class) as well as monitor for other cardiac events as a safety assessment. | — |
Countries
Austria, Belgium, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Poland, Spain
Outcome results
None listed