Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTechnical University of Munich

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Exercise training

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators