Clinical Trial

Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy

Study acronym: MavaEnEx
Recruiting
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Summary
Patients with hypertrophic obstructive cardiomyopathy and New York Heart Association Class I-II under stable treatment with mavacamten (at least 12 weeks without change of dosage) and a peak left ventricular outflow tract obstruction \<50mmHg undergo either 6 weeks of structured moderate intensity endurance and resistance training (supervised, 3x/week, intervention, IT) or usual care (UC). Patients within 1 hour of travel to the training venue will be referred to IT, while those with more than 1 hour will join UC. At baseline (visit 1, V1) and after 6 weeks of exercise intervention (visit 2, V2) all patients undergo a medical exam, resting and stress echocardiography and receive a questionnaire on the quality of life (Kansas City Cardiomyopathy Questionnaire). Cardiac biomarkers are assessed. 3 hours after stress echocardiography cardiopulmonary exercise testing is performed to measure peak oxygen consumption (VO2peak). The primary outcome is safety. Secondary outcomes include the change of VO2peak, changes in cardiac biomarkers, resting and stress echocardiographic variables, quality of life and variables of cardiopulmonary exercise testing from V1 to V2.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-19; most recent amendment 2025-12-18.
Trial Details
NCT Number NCT07077005
Lead Sponsor Technical University of Munich
Conditions Cardiomyopathy, Hypertrophic
Enrollment 24 participants
Start Date 2025-11-01
Primary Completion 2026-10-31 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-26