A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Part of paid clinical trials in West Hollywood, California.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT06112743
- Phase
- PHASE4
- Status
- Active Not Recruiting
Conditions
- Cardiomyopathy, Hypertrophic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Mavacamten — DRUGSpecified dose on specified days
Study Details
The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) \[New York Heart Association (NYHA) Functional Class II or III\].
Key Dates
- Start date
- Jan 24, 2024
- Status verified
- Sep 2025
- Primary completion
- Jul 9, 2026
- Completion
- Jul 9, 2026
Study Design
- Enrollment
- 63 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Mavacamten
Primary Outcome Measure
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48 [ Time Frame: At week 48 ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0087 | West Hollywood | California | 90048-1804 | - |
| Local Institution - 0003 | Atlanta | Georgia | 30309 | - |
| Local Institution - 0093 | Boston | Massachusetts | 02114 | - |
| Local Institution - 0090 | Cleveland | Ohio | 44106 | - |
| Local Institution - 0086 | Pittsburgh | Pennsylvania | 15212-4756 | - |
| Local Institution - 0017 | Houston | Texas | 77030 | - |
| Local Institution - 0035 | Murray | Utah | 84107-5701 | - |
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