Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05818605

The EXerCise traIning To rEcovery in HCM Trial

Led by University of California, San Francisco · Updated on 2025-11-20

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying adults aged 18 to 80 with hypertrophic cardiomyopathy (HCM) to compare the effects of moderate intensity exercise training against usual physical activity. This trial aims to evaluate how these approaches impact symptoms related to HCM and heart function over 24 weeks. Approximately 70 participants will be randomly assigned to either an exercise group or a usual activity group for this randomized, controlled, and single-blinded study. Participants assigned to the exercise group will begin with a supervised session and consultation with an exercise physiologist in a hospital setting. Afterward, they will continue exercise sessions at home with video supervision three times per week for 24 weeks. Those in the usual activity group will maintain their current physical activity levels without starting or increasing exercise during the study period. Throughout the 24 weeks, participants will undergo various assessments including physical exams, questionnaires, 12-lead ECGs, biomarker testing, echocardiograms, cardiac MRI, PET scans, and cardiopulmonary exercise testing. Researchers will measure changes in maximum oxygen uptake (VO2 max) and heart muscle function to monitor response to the interventions. Safety and adherence will be tracked, and the study will conclude after the 24-week follow-up period.

CONDITIONS

Brief Title

Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy defined by specific heart wall thickness criteria
  • Left ventricular outflow tract gradient less than 30 mmHg at rest and with provocation
  • Left ventricular ejection fraction 50% or greater
  • Access to exercise equipment at home or at a fitness center
  • Ability to complete study-related testing including online surveys and smartphone use
  • Ability to perform 24 weeks of exercise training
Not Eligible

You will not qualify if you...

  • History of exercise-induced fainting or ventricular arrhythmias
  • Left ventricular outflow tract obstruction currently being evaluated for septal reduction therapy or within 3 months after therapy
  • History of septal reduction therapy (surgery or ablation)
  • History of implantable cardioverter defibrillator placement in the previous 3 months
  • History of low blood pressure response during exercise testing
  • Clinical worsening in the past 3 months with severe heart failure or angina symptoms
  • Left ventricular ejection fraction less than 50%
  • Life expectancy less than 12 months
  • Pregnant or planning pregnancy
  • Inability to exercise due to medical or other reasons
  • Unwillingness to avoid competitive sports, burst activity, or heavy isometric exercise if assigned to the non-exercise group

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 weeks

Participants randomized to the exercise group will complete a supervised in-hospital exercise consultation followed by home-based video-supervised exercise sessions. Those in the usual activity group will maintain their current physical activity without changes.

1 supervised in-hospital visit and thrice-weekly home exercise sessions

Trial Site Locations

Total: 1 location

1

University of California - San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

C

Cynthia Partida-Higuera, CCRP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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