Study of Exercise Training in Hypertrophic Cardiomyopathy

University of Michigan136 enrolled

Overview

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.

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 peak VO2 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Exercise trainingBEHAVIORAL

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 70% of heart rate reserve and exercising 60 minutes 4-7 days per week.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Stanford University

Stanford, California, United States

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Change in Peak Oxygen Consumption (Peak VO2)

Cardiopulmonary exercise testing was performed at study enrollment and termination (4 months apart). Peak VO2 was measured at each time point in each subject and change in peak VO2 over time was calculated. The change in Peak VO2 was compared between the study arms.

Time frame: At study Enrollment and 4 months later

Data from ClinicalTrials.gov

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