NCT07077005Recruiting
Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy
MavaEnEx-HOCM: Mavacamten Enables Exercise Training in Patients With Hypertrophic Obstructive CardioMyopathy. A Pilot Study
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 10 Jul 2025
- Start date
- 1 Nov 2025
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Technical University of Munich
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07077005
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 1 Nov 2025 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Syncope or sustained ventricular tachycardia within 6 months prior to study inclusion
- Previous transcoronary ablation of septal hypertrophy or surgical myectomy
- Prior implantable cardioverter defibrillator-implantation
Other illness
- Sudden Cardiac Death Risk Score ≥4%
Lab values
- Corrected QT-interval (Fridericia-formula) ≥ 500 ms
Other
- Paroxysmal or intermittent atrial fibrillation (AF) on screening electrocardiogram
- Persistent or permanent AF without anticoagulation for ≥4 weeks
- Ventricular tachycardia, significant ST-elevation or depression upon baseline cardiopulmonary exercise testing
- ≥ grade II valve insufficiencies or stenoses during resting echocardiography
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Technical University Munich Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.