RecruitingNot ApplicableNCT05818605

Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy

The EXerCise traIning To rEcovery in HCM Trial


Sponsor

University of California, San Francisco

Enrollment

70 participants

Start Date

Feb 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and cardiac function. About 70 participants will be recruited and randomized on a 1:1 ratio to either moderate intensity training or usual physicial activity interventions. Patients will be followed during a period of 24 weeks and assesesments as physical examination, questionnaires, 12 lead ecg's, biomarker levels, echocardiogram, Cardiac Magnetic resonance, PET and CPET will be performed to evaluate their response to the intervention.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether a structured exercise training program can safely improve exercise tolerance in patients with non-obstructive hypertrophic cardiomyopathy (HCM) — a genetic heart condition where the heart muscle becomes abnormally thick, limiting its ability to fill with blood. Patients with HCM are often told to avoid vigorous exercise out of fear of triggering dangerous arrhythmias, but many experts now believe that moderate, supervised exercise may actually be beneficial rather than harmful. Eligible participants are adults aged 18 to 80 with confirmed non-obstructive HCM (without significant outflow tract blockage) and a preserved ejection fraction, who have access to exercise equipment and can use a smartphone to complete surveys. Key exclusions include a history of exercise-induced fainting or dangerous arrhythmias, recent ICD implantation, clinical decompensation in the past 3 months, and inability to exercise. Participants are randomized to an exercise program or standard care and followed for 24 weeks. Exercise intolerance is one of the most limiting symptoms of HCM, preventing patients from working, socializing, and enjoying a normal life. If this study demonstrates that exercise is safe and effective, it could overturn decades of overly conservative advice and give HCM patients a powerful, non-pharmacological tool to improve their fitness, symptoms, and mental health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALModerate Intensity Exercise Program

Subjects randomized to the EXER arm will undergo 24 weeks of Moderate Intensity Exercise Training (MIET). Patients will be signed up for 60-minute exercise sessions, 3 times a week


Locations(1)

University of California - San Francisco

San Francisco, California, United States

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NCT05818605


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