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Study of Exercise Training in Hypertrophic Cardiomyopathy
Not Recruiting
Trial ID: NCT01127061
Purpose
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.
Official Title
A Randomized Trial of Moderate Intensity Exercise Training in Hypertrophic Cardiomyopathy
Stanford Investigator(s)
Euan A. Ashley
Associate Dean, School of Medicine, Roger and Joelle Burnell Professor of Genomics and Precision Health, Professor of Medicine (Cardiovascular Medicine), of Genetics, of Biomedical Data Science and, by courtesy, of Pathology
Eligibility
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.
Intervention(s):
behavioral: Exercise training
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Heidi Salisbury, BS, RN, MSN
650-736-7878