RecruitingNot ApplicableNCT07077005

Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy

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

Sponsor

Technical University of Munich

Enrollment

24 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiomyopathy, Hypertrophic

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria6

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 Criteria9

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%