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Search / Trial NCT07077005

Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy

Launched by TECHNICAL UNIVERSITY OF MUNICH · Jul 19, 2025

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Exercise Capacity Mavacamten Safety Exercise Training

ClinConnect Summary

This clinical trial is studying whether a specific exercise program can help people with hypertrophic obstructive cardiomyopathy (a condition where the heart muscle is thickened and blocks blood flow) who are already being treated with a medicine called mavacamten. The goal is to see if doing regular, supervised moderate exercise over six weeks improves heart and lung fitness, measured by how much oxygen the body can use during exercise.

To join the study, participants need to be adults diagnosed with this heart condition, have been on a stable dose of mavacamten for at least 12 weeks, and have certain heart function measurements within a safe range. People with very severe symptoms or certain heart rhythm problems are not eligible. Participants will either follow the exercise program three times a week or continue their usual care, depending on how close they live to the exercise location. Before and after the six weeks, they will have medical exams, heart imaging tests, and complete questionnaires about their quality of life. The study will also monitor safety and other heart health measures to better understand the benefits and risks of adding exercise to treatment with mavacamten.

Gender

ALL

Eligibility criteria

  • 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%

About Technical University Of Munich

The Technical University of Munich (TUM) is a leading research institution in Germany, renowned for its commitment to excellence in education, innovation, and technology transfer. With a strong emphasis on interdisciplinary collaboration, TUM fosters advancements in various fields, including medicine and life sciences. The university actively engages in clinical research, aiming to translate scientific discoveries into practical applications that improve patient outcomes. Through its state-of-the-art facilities and a network of partnerships with hospitals and industry, TUM is dedicated to conducting rigorous clinical trials that adhere to the highest ethical standards and contribute significantly to the advancement of healthcare.

Locations

Munich, Bavaria, Germany

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported