Actively Recruiting
Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy
Led by Technical University of Munich · Updated on 2025-12-26
24
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of hypertrophic obstructive cardiomyopathy
- At least 12 weeks of unchanged mavacamten dosage
- Peak left ventricular outflow tract gradient 50 mmHg or less at rest and during stress echocardiography
- Left ventricular ejection fraction 50% or higher at study inclusion
- New York Heart Association Class I or II
You will not qualify if you...
- Syncope or sustained ventricular tachycardia within 6 months before study inclusion
- Corrected QT-interval (Fridericia-formula) 500 ms or greater
- Paroxysmal or intermittent atrial fibrillation on screening electrocardiogram
- Persistent or permanent atrial fibrillation without anticoagulation for 4 weeks or more
- Previous transcoronary septal ablation or surgical myectomy
- Ventricular tachycardia, significant ST-elevation or depression during baseline cardiopulmonary exercise testing
- Valve insufficiencies or stenoses grade II or higher during resting echocardiography
- Prior implantable cardioverter defibrillator implantation
- Sudden Cardiac Death Risk Score 4% or higher
AI-Screening
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Trial Site Locations
Total: 1 location
1
Technical University Munich
Munich, Bavaria, Germany, 81675
Actively Recruiting
Research Team
S
Simon Wernhart, MD
CONTACT
M
Martin Halle, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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