Exercise Study Including Patients With Hypertrophic Cardiomyopathy

NCT01165749 | Unknown

• 2 other identifiers: SU-05062010-590218518
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy, Hypertrophic

Outcome Measures

Primary Outcomes (1)

• Improvement in ability to perform activities and tasks.

  4 months

Secondary Outcomes (1)

• Improvement in heart size and function and quality of life (QOL).

  4 months

Interventions

stop exercising BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with hypertrophic cardiomyopathy

You may qualify if:

• Ages 18 - 80 years old.
• Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) \> 13 mm in any wall segment.
• Exercise £ 30 minutes, 1 day per week for the previous 3 months.
• Agreement to be a participant in the study protocol and willing/able to return for follow-up.

You may not qualify if:

• History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).
• Medically refractory LV 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 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).
• Pregnancy.
• ICD placement in last 3 months or scheduled.
• Life expectancy less than 12 months.
• Inability to exercise due to orthopedic or other non-cardiovascular limitations.

Sponsors & Collaborators

• Stanford University: lead
• University of Michigan: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Dr. Euan Ashley MRCP, DPhil

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Garrett

CONTACT

(650) 736-7878; lisamariegarrett@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 20, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: July 20, 2010

Record last verified: 2010-07

Locations

US (1)