Status:
ACTIVE_NOT_RECRUITING
Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy
Lead Sponsor:
Xu Liu
Conditions:
HCM - Hypertrophic Cardiomyopathy
Mavacamten
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aimed to evaluate the efficacy and safety of Mavacamten compared to no treatment in patients with symptomatic latent obstructive hypertrophic cardiomyopathy. The trial was randomized into t...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Weight greater than 45 kg.
- Adequate acoustic windows to allow for accurate transthoracic echocardiograms (TTEs).
- Diagnosis of latent obstructive hypertrophic cardiomyopathy, in accordance with the current guidelines of the American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Chinese Society of Cardiology.
- Left ventricular ejection fraction (LVEF) ≥55% at rest, confirmed by the echocardiography core laboratory.
- New York Heart Association (NYHA) Class II or III symptoms at the time of screening.
- Resting oxygen saturation ≥90% at the time of screening.
Exclusion
- Any acute or severe comorbidities (e.g., severe infections or hematological, renal, metabolic, gastrointestinal, or endocrine dysfunction).
- Currently using or having used prohibited medications within 14 days prior to screening, such as cytochrome CYP2C19 inhibitors (e.g., omeprazole or esomeprazole) or strong CYP3A4 inhibitors.
- Life expectancy of less than 1 year.
- Pregnant or breastfeeding women.
- History of syncope or sustained ventricular tachyarrhythmia during exercise within the past 6 months.
- Atrial fibrillation (AF).
- Patients currently receiving or planning to receive treatment with disopyramide, cibenzoline, ranolazine, or a combination of beta-blockers with verapamil or diltiazem.
Key Trial Info
Start Date :
April 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06947590
Start Date
April 20 2025
End Date
February 1 2026
Last Update
April 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Chest Hospital
Shanghai, China