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

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