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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 the change of VO2peak from V1 to V2. Secondary outcomes include safety, changes in cardiac biomarkers, resting and stress echocardiographic variables, quality of life and variables of cardiopulmonary exercise testing.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Technical University Munich
RECRUITING
Munich
Contact Information
Primary
Simon Wernhart, MD
simon.wernhart@mri.tum.de
00498941406774
Backup
Martin Halle, Professor
martin.halle@mri.tum.de
00498941406774
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 24
Treatments
Experimental: Exercise
Supervised combined endurance and resistance training on top of mavacamten therapy
No_intervention: Usual Care
No supervised exercise training
Sponsors
Leads: Technical University of Munich

This content was sourced from clinicaltrials.gov