Study of Exercise Training in Hypertrophic Cardiomyopathy

Completed · Not applicable

Conditions studied: Cardiomyopathy, Hypertrophic

In brief

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.

Key facts

Study ID

NCT01127061

Run by

University of Michigan

People needed

136

Starts

2010-04-01

Expected to finish

2016-11-01

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University — Stanford, California, United States
• University of Michigan Cardiovascular Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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