N/A
N=136
Study of Exercise Training in Hypertrophic Cardiomyopathy
Cardiomyopathy, Hypertrophic
Bottom Line
View on ClinicalTrials.gov: NCT01127061 ↗Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Change in Peak Oxygen Consumption (Peak VO2) — 1.35; 0.08 mL/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise training (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak Oxygen Consumption (Peak VO2) |
1.35; 0.08 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01127061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.