Exercise training: Supervised, combined endurance and resistance training
Study 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
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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%
Primary outcome measure(s)
Incidence of Treatment-Emergent Adverse Events — 6 weeks Safety is defined by the abscence of adverse or serious adverse events during exercise training or within 1h of exercise termination. Adverse events include non-sustained ventricular tachycardia (nsVT) and atrial fibrillation. Serious adverse events contain hospitalization due to cardiovascular events, sustained ventricular tachycardia, nsVT with hemodynamic compromise, syncope, cardiac arrest and sudden cardiac death. Higher scores mean a worse outcome.
Trial sites (1)
Facility
City
Region
Status
Technical University Munich
Munich
Bavaria
Recruiting
More Technical University of Munich trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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