Study of Exercise Training in Hypertrophic Cardiomyopathy
Trial ID or NCT#
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.
A Randomized Trial of Moderate Intensity Exercise Training in Hypertrophic Cardiomyopathy
- - 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.
- - 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.
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Heidi Salisbury, BS, RN, MSN
View on ClinicalTrials.gov