A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US
Active, not recruiting
- Conditions
- Obstructive Hypertrophic Cardiomyopathy (oHCM)
- Interventions
- Registration Number
- NCT07107373
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the real-world safety and effectiveness of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) initiated on mavacamten at certain high volume HCM centers in the US
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Age ≥ 18 years at the index date
- Prescription of mavacamten for the treatment of Obstructive hypertrophic cardiomyopathy (oHCM) with NYHA Class II or III
- ≥ 12 weeks of follow-up after prescription of mavacamten, except for the baseline data reporting
Exclusion Criteria
- Data collection as part of a clinical trial during the study period
- Participation in a myosin inhibitor clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants receiving treatment mavacamten Mavacamten -
- Primary Outcome Measures
Name Time Method New York Heart Association (NYHA) functional class Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index Left ventricular outflow tract (LVOT) gradient and associated parameters Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index Left ventricular ejection fraction (LVEF) and associated parameters Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index
- Secondary Outcome Measures
Name Time Method Mavacamten dose at initiation Day 1 Mavacamten dose change Up to 72 weeks Reason for mavacamten dose change Up to 72 weeks Reason for mavacamten permanent discontinuation Up to 72 weeks Other cardiovascular-related treatments prescribed Up to 72 weeks Reason for treatment interruption Up to 72 weeks Prior Obstructive hypertrophic cardiomyopathy (oHCM) therapies Baseline Concurrent Obstructive hypertrophic cardiomyopathy (oHCM) therapies Up to 72 weeks
Trial Locations
- Locations (1)
University of California, San Francisco (UCSF)
🇺🇸San Francisco, California, United States
University of California, San Francisco (UCSF)🇺🇸San Francisco, California, United States