Clinical Trial: Study of Exercise Training in Hypertrophic Cardiomyopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Trial of Moderate Intensity Exercise Training in Hypertrophic Cardiomyopathy

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

Detailed Summary: 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.
Sponsor: University of Michigan

Current Primary Outcome: Change in peak oxygen consumption [ Time Frame: At study initiation and 4 months later ]

Cardiopulmonary exercise testing in combination with echocardiography will be performed at study initiation and termination (4 months).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions. [ Time Frame: At study initiation and 4 months later ]
    Echocardiography and cardiac magnetic resonance imaging will be performed at study initiation and termination (4 months). Cardiac magnetic resonance imaging will only be performed in those who do not have implantable devices (ICDs).
  • Degree of left ventricular outflow obstruction. [ Time Frame: At study initiation and 4 months later ]
    Cardiopulmonary exercise testing in combination with echocardiography will be performed at study initiation and termination (4 months).
  • Systolic or diastolic function. [ Time Frame: At study initiation and 4 months later ]
    Echocardiography will be performed at study initiation and termination.
  • Scar volume by MRI [ Time Frame: At study initiation and 4 months later ]
    Cardiac magnetic resonance imaging (MRI) will be performed in all patients without implantable devices at study initiation and termination (4 months).
  • Stretch activation markers. [ Time Frame: At study initiation and 4 months later ]
    Blood will be drawn to evaluate stretch activation markers at study initiation and termination (4 months).
  • Quality of life indicators. [ Time Frame: At study initiation and 4 months later ]
    Quality of life questionnaires will be administered at study initiation and termination (4 months).


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: May 17, 2010
Date Started: April 2010
Date Completion:
Last Updated: March 10, 2017
Last Verified: March 2017