Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Cardiomyopathy, Hypertrophic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 car...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:.
- Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mmHg and ≥ 50 mmHg after Valsalva or after exercise.
- Left ventricular ejection fraction (LVEF) ≥ 55% at rest.
- New York Heart Association (NYHA) functional class II or III symptoms.
- Exclusion Criteria
- A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM.
- Documented obstructive coronary artery disease or history of myocardial infarction.
- A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening.
- An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR).
- Other protocol-defined inclusion/exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06112743
Start Date
January 24 2024
End Date
July 9 2026
Last Update
September 22 2025
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution - 0087
West Hollywood, California, United States, 90048-1804
2
Local Institution - 0003
Atlanta, Georgia, United States, 30309
3
Local Institution - 0093
Boston, Massachusetts, United States, 02114
4
Local Institution - 0090
Cleveland, Ohio, United States, 44106