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Exercise Study Including Patients With Hypertrophic Cardiomyopathy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Stanford University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165749
First Posted: July 20, 2010
Last Update Posted: July 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Michigan
Information provided by:
Stanford University
  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:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Improvement in ability to perform activities and tasks. [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Improvement in heart size and function and quality of life (QOL). [ Time Frame: 4 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 16, 2010
First Posted: July 20, 2010
Last Update Posted: July 20, 2010
Last Verified: July 2010

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