Mavacamten plus supervised exercise for people with obstructive hypertrophic cardiomyopathy

MavaEnEx-HOCM: Mavacamten Enables Exercise Training in Patients With Hypertrophic Obstructive CardioMyopathy. A Pilot Study

This trial tests whether supervised moderate endurance and resistance training is safe and improves fitness for adults with obstructive hypertrophic cardiomyopathy who have been on stable mavacamten treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Technical University of Munich (other)
• Locations: 1 site (Munich, Bavaria)
• Trial ID: NCT07077005 on ClinicalTrials.gov

What this trial studies

Adults with hypertrophic obstructive cardiomyopathy who have been on a stable mavacamten dose for at least 12 weeks, have NYHA class I–II, LVEF ≥50% and a peak LVOT gradient ≤50 mmHg undergo either 6 weeks of supervised moderate endurance and resistance training (three times per week) or usual care. Allocation to supervised training versus usual care is determined by travel time to the training site (within 1 hour → training; >1 hour → usual care) at a single center in Munich. Baseline and 6-week follow-up include medical exam, resting and stress echocardiography, blood cardiac biomarkers, a quality-of-life questionnaire (Kansas City Cardiomyopathy Questionnaire) and cardiopulmonary exercise testing to measure peak VO2. Continuous symptom-triggered ECG monitoring with smart watches is provided and the primary outcome is safety, with secondary outcomes including exercise capacity, echocardiographic measures, biomarkers and quality of life.

Who should consider this trial

Good fit: Adults (≥18 years) with obstructive hypertrophic cardiomyopathy, NYHA class I–II, left ventricular ejection fraction ≥50%, peak LVOT gradient ≤50 mmHg, and at least 12 weeks of unchanged mavacamten therapy are ideal candidates.

Not a fit: Patients with recent syncope or sustained ventricular tachycardia, significant valve disease, prior septal reduction or ICD implantation, uncontrolled or unanticoagulated atrial fibrillation, a high sudden cardiac death risk score, or those who cannot attend the training site are unlikely to benefit from the supervised exercise intervention.

Why it matters

Potential benefit: If successful, this could show that supervised moderate exercise is safe for selected patients on mavacamten and can improve fitness and quality of life.

How similar studies have performed: Previous supervised exercise programs in carefully selected HCM patients have shown safety and improvements in fitness, but combining structured training specifically while on mavacamten is a novel approach with limited prior data.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years of age
* Diagnosis of hypertrophic obstructive cardiomyopathy
* ≥12 weeks of unchanged dosage of mavacamten
* Peak left ventricular outflow tract gradient ≤ 50 mmHg at rest and during stress echocardiography
* Left ventricular ejection fraction ≥50% at study inclusion
* New York Heart Association classes I-II

Exclusion Criteria:

* Syncope or sustained ventricular tachycardia within 6 months prior to study inclusion
* Corrected QT-interval (Fridericia-formula) ≥ 500 ms
* Paroxysmal or intermittent atrial fibrillation (AF) on screening electrocardiogram
* Persistent or permanent AF without anticoagulation for ≥4 weeks
* Previous transcoronary ablation of septal hypertrophy or surgical myectomy
* Ventricular tachycardia, significant ST-elevation or depression upon baseline cardiopulmonary exercise testing
* ≥ grade II valve insufficiencies or stenoses during resting echocardiography
* Prior implantable cardioverter defibrillator-implantation
* Sudden Cardiac Death Risk Score ≥4%

Where this trial is running

Munich, Bavaria

• Technical University Munich — Munich, Bavaria, Germany (RECRUITING)

Study contacts

• Study coordinator: Simon Wernhart, MD

Conditions: Cardiomyopathy, Hypertrophic, exercise capacity, mavacamten, safety, exercise training