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Exercise Study Including Patients With Hypertrophic Cardiomyopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Michigan
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01165749
First received: July 16, 2010
Last updated: July 19, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention
Cardiomyopathy, Hypertrophic
 Behavioral: stop exercising

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomized Trial of Moderate Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Improvement in ability to perform activities and tasks. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in heart size and function and quality of life (QOL). [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients diagnosed with hypertrophic cardiomyopathy

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165749

Contacts
Contact: Lisa Garrett (650) 736-7878 lisamariegarrett@gmail.com

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Lisa Garrett     650-736-7878     lisamariegarrett@gmail.com    
Contact: Terra Coakley     (650) 725-6186     tcoakley@stanford.edu    
Principal Investigator: Dr. Euan Ashley MRCP, DPhil            
Sponsors and Collaborators
Stanford University
University of Michigan
Investigators
Principal Investigator: Dr. Euan Ashley MRCP, DPhil Stanford University
  More Information

No publications provided

Responsible Party: Dr. Euan Ashley MRCP, DPhil, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01165749     History of Changes
Other Study ID Numbers: SU-05062010-5902, 18518
Study First Received: July 16, 2010
Last Updated: July 19, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
 Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013