Cardiomyopathy, Hypertrophic Clinical Trial
Official title:
A Randomized Trial of Moderate Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy
The long term health and cardiovascular benefits of a regular exercise program have been well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy (HCM). However, data on potential benefits of recreational exercise, useful parameters for risk stratification, and methods of devising individual exercise prescriptions are completely lacking. The specific aims of this study are: 1) to devise a safe moderate intensity exercise training program in patients with HCM, and 2) to determine whether exercise training improves ability to perform activities and tasks, heart size and function, and quality of life in patients with HCM.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | April 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Ages 18 - 80 years old. 2. Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) > 13 mm in any wall segment. 3. Exercise £ 30 minutes, 1 day per week for the previous 3 months. 4. 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). 2. Medically refractory LV outflow tract obstruction being evaluated for septal reduction therapy. 3. Less than 3 months post septal reduction therapy (surgery or catheter based intervention). 4. Hypotensive response to exercise (> 20 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure). 5. Pregnancy. 6. ICD placement in last 3 months or scheduled. 7. Life expectancy less than 12 months. 8. Inability to exercise due to orthopedic or other non-cardiovascular limitations. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in ability to perform activities and tasks. | 4 months | No | |
Secondary | Improvement in heart size and function and quality of life (QOL). | 4 months | No |
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