Study of Exercise Training in Hypertrophic Cardiomyopathy

Trial ID or NCT#

NCT01127061

Status

not recruiting iconNOT RECRUITING

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 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 Criteria

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

Investigator(s)

Euan A. Ashley
Euan A. Ashley
Cardiologist, Heart failure cardiologist
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

Contact us to find out if this trial is right for you.

CONTACT

Heidi Salisbury, RN, MSN
(650) 736-7878