An interventional study of Exercise training in Cardiomyopathy, Hypertrophic, sponsored by Technical University of Munich. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Other
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.
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 at rest and during peak exercise undergo either 6 weeks of structured moderate intensity endurance and resistance training (supervised, 3x/week, intervention group, IT) or usual care (UC). UC will receive standard recommendations on physical activity but no supervised training. All patients receive smart watches and electrocardiograms can be triggered upon symptoms.
Patients previously treated with transcoronary septal ablation or surgical myectomy, more than low grade valve pathology during resting echocardiography, syncope or sustained ventricular tachycardia within 6 months prior to study inclusion, prior implantable cardioverter defibrillator implantation, persistent or permanent atrial fibrillation (AF) without anticoagulation for ≥4 weeks or paroxysmal or intermittent AF on screening electrocardiogram, or a corrected QT-interval (Fridericia-formula) ≥ 500 ms will be excluded. Patients with a Sudden Cardiac Death Risk Score ≥4% are excluded from the study.
Due to the rare nature of the disease and the large geographical variation, patients within 1 hour of travel to the training site will join IT, patients travelling more than 1 hour will be grouped into 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 (CPET) is performed to measure peak oxygen consumption (VO2peak).
The primary outcome is safety (no ventricular arrhythmias during exercise intervention or within 1 hour after completion of exercise). Secondary outcomes include changes in VO2peak, changes in cardiac biomarkers, resting and stress echocardiographic variables, quality of life and CPET variables. Physicians performing the echocardiographies and CPET analyses will be blinded to group allocation.
347 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 110 are open to participants now.
This study's planned enrollment of 24 is below the median of 59 across 171 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Browse Cardiomyopathy, Hypertrophic studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Supervised combined endurance and resistance training on top of mavacamten therapy
Other: Exercise training
No supervised exercise training
Supervised, combined endurance and resistance training
Incidence of Treatment-Emergent Adverse Events
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.
Time frame: 6 weeks
Change of resting left ventricular ejection fraction
Changes of resting left ventricular ejection fraction between visit 1 and visit 2 between the exercise and usual care group.
Time frame: 6 weeks
Change of tissue Doppler velocity during peak exercise
Changes of tissue Doppler velocity (average between medial and lateral velocities) during peak exercise between visit 1 and visit 2 between the exercise and usual care group. Higher scores mean a better diastolic function.
Time frame: 6 weeks
Change of minute ventilation to carbon dioxide production
Changes of minute ventilation to carbon dioxide production between visit 1 and visit 2 between the exercise and usual care group. Higher scores mean a worse outcome.
Time frame: 6 weeks
Change of Kansas City Cardiomyopathy Score
Changes of quality of life between visit 1 and visit 2 between the exercise and usual care group. Quality of life is assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ), a difference of at least five points is considered significant. KCCQ ranges from 0 to 100 points, while 0 means worst quality of life, 100 being best quality of life.
Time frame: 6 weeks
Change of N-terminal pro-B-type natriuretic peptide and troponin I
Changes of cardiac biomarkers N-terminal pro-B-type natriuretic peptide (NTproBNP, pg/ml) and troponin I (pg/ml) between visit 1 and visit 2 between the exercise and usual care group. Higher scores mean a worse outcome.
Time frame: 6 weeks
Differences of incidence of atrial fibrillation, atrial or ventricular tachycardia on electrocardiograms
Between group differences of incidence of atrial fibrillation, atrial tachycardia or ventricular tachycardia on electrocardiograms triggered by the smart watch electrocardiograms or displayed by electrocardiograms during visits.
Time frame: 6 weeks
Change of peak oxygen consumption
Changes of peak oxygen consumption between visit 1 and visit 2 between the exercise and usual care group. A change of 1.5mL/kg/min is considered significant. Higher scores mean a better outcome.
Time frame: 6 weeks
Plan to share: No — Data will be made available on reasonable request to the principal investigator
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Technical University of Munich