This trial is active, not recruiting.

Condition cardiomyopathy, hypertrophic
Treatment exercise training
Sponsor University of Michigan
Collaborator Stanford University
Start date April 2010
End date September 2015
Trial size 128 participants
Trial identifier NCT01127061, RESET-HCM


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 and quality of life, with neutral effects on the clinical characteristics.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Participants in the exercise group will undergo 4 months of training, 4-7 days per week with a minimum of 20 minutes per day. The protocol will be custom designed in consultation with an exercise physiologist based on data from the initial cardiopulmonary stress test. Exercise regimen will begin at a low level of intensity then increase in duration and training intensity to a goal of 60 minutes a day and 80% of the heart rate reserve during the 1st month of the study protocol with maintenance of the program thereafter. There is no need to come to a participating site for actually doing the exercise regimen. No strength training or burst activity will be prescribed and all activities will fall well within the recommended national guidelines for recreational exercise.
exercise training
4 months of exercise training that is custom-designed based on individual cardiopulmonary stress test data. Regimen starts at low intensity (60% of heart rate reserve) and frequency (20 minutes, 3 days per week) and increases with a goal of 80% of heart rate reserve and exercising 60 minutes 4-7 days per week.
(No Intervention)
Participants in this group are not restricted in their activities. They simply are not guided in their physical activities by the study team. At the end of the 4 month study period, they will also receive an individualized exercise prescription for personal use.

Primary Outcomes

Change in peak oxygen consumption
time frame: At study initiation and 4 months later

Secondary Outcomes

Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions.
time frame: At study initiation and 4 months later
Degree of left ventricular outflow obstruction.
time frame: At study initiation and 4 months later
Systolic or diastolic function.
time frame: At study initiation and 4 months later
Scar volume by MRI
time frame: At study initiation and 4 months later
Stretch activation markers.
time frame: At study initiation and 4 months later
Quality of life indicators.
time frame: At study initiation and 4 months later

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Age ≥ 18 years and ≤ 80. - Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy > 13 mm in any wall segment. - Time set aside specifically for aerobic exercise ≤ 30 minutes, ≤ 1 day per week in the previous 3 months. - 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. - 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.

Additional Information

Official title A Randomized Trial of Moderate Intensity Exercise Training in Hypertrophic Cardiomyopathy
Principal investigator Sara Saberi, MD
Description The goal of this randomized clinical pilot trial is to establish the safety profile and potential benefits of moderate intensity exercise in patients with hypertrophic cardiomyopathy (HCM). Participation in competitive athletics is associated with an increased risk of sudden cardiac death (SCD) in individuals with structural heart disease, including HCM. This has appropriately led to the establishment of national guidelines based on expert opinion that discourage participation in high intensity competitive sports, burst exertion (e.g., sprinting), or isometric exercise (e.g., heavy lifting). Non-competitive, low to moderate intensity exercise is allowable, although many physicians and HCM patients are still understandably apprehensive. Data on the safety of a recreational exercise program, and how to gauge appropriate intensity level, are desperately needed so that HCM patients can reap the well established health benefits of regular physical activity. Limited, but compelling animal data suggest that moderate intensity exercise is not only safe, but may also prevent or even reverse cardiac hypertrophy, fibrosis, myocellular disarray, and apoptosis associated with HCM. There are no published studies on exercise in patients with HCM, although large clinical trials in heart failure have shown exercise training to be safe, to improve functional capacity and quality of life, and to lower cardiovascular mortality. The pilot randomized control trial proposed here is the first to determine the safety of moderate intensity exercise training and explore its potential benefits in patients with HCM.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Michigan.