CompletedNot Applicable

Study of Exercise Training in Hypertrophic Cardiomyopathy

United States136 participantsStarted 2010-04

Plain-language summary

The investigators propose a pilot randomized controlled trial to determine the safety and potential benefits of moderate intensity exercise in patients with hypertrophic cardiomyopathy. The investigators hypotheses are that exercise parameters derived from a baseline cardiopulmonary exercise test will target an appropriately safe level of exercise intensity that will not cause significant arrhythmias or exacerbate symptoms and that exercise training for 4 months will result in significant improvements in peak oxygen consumption (peak VO2) and quality of life, with neutral effects on the clinical characteristics.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years and ≤ 80. * Diagnosis of HCM, defined by the presence of unexplained left-ventricular hypertrophy \> 13 mm in any wall segment. * Agreement to be a participant in the study protocol and willing/able to return for follow-up. Exclusion Criteria: * History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia). * Medically refractory left ventricular outflow tract obstruction being evaluated for septal reduction therapy. * Less than 3 months post septal reduction therapy (surgery or catheter based intervention). * Hypotensive response to exercise (\> 20 mm Hg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure). * Pregnancy. * Implantable Cardioverter-Defibrillator (ICD) placement in last 3 months or scheduled. * Left ventricular systolic dysfunction (left ventricular ejection fraction \< 55% by echocardiography). * Worsening clinical status in the last 3 months, advanced heart failure (New York Heart Association class IV symptoms) or angina (Canadian Cardiovascular Society class IV symptoms). * Life expectancy less than 12 months. * Inability to exercise due to orthopedic or other non-cardiovascular limitations. * Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Peak Oxygen Consumption (Peak VO2)

Timeframe: At study Enrollment and 4 months later

Trial details

NCT IDNCT01127061

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

Results submitted2018-01-26

View on ClinicalTrials.gov More Cardiomyopathy, Hypertrophic trials