Exercise Study Including Patients With Hypertrophic Cardiomyopathy

• Conditions: Cardiomyopathy, Hypertrophic

• Registration Number: NCT01165749
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Status Verified: 2010-07
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-19
• Last Update Submitted: 2010-07-19
• Study First Posted: 2010-07-20
• Last Update Posted: 2010-07-20
• Primary Completion: 2011-12
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in ability to perform activities and tasks.	4 months

Secondary Outcome Measures

Name	Time	Method
Improvement in heart size and function and quality of life (QOL).	4 months

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States