Exercise Study Including Patients With Hypertrophic Cardiomyopathy

NCT ID: NCT01165749

Last Updated: 2010-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-04-30

Brief Summary

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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

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Conditions

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Cardiomyopathy, Hypertrophic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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stop exercising

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Stanford University School of Medicine

Principal Investigators

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Dr. Euan Ashley MRCP, DPhil

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lisa Garrett

Role: CONTACT

(650) 736-7878

Facility Contacts

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Lisa Garrett

Role: primary

650-736-7878

Terra Coakley

Role: backup

(650) 725-6186

Other Identifiers

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18518

Identifier Type: -

Identifier Source: secondary_id

SU-05062010-5902

Identifier Type: -

Identifier Source: org_study_id

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