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Study of Exercise Training in Hypertrophic Cardiomyopathy (RESET-HCM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Michigan
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Sara Saberi, University of Michigan
ClinicalTrials.gov Identifier:
NCT01127061
First received: May 17, 2010
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

The investigators propose a pilot randomized controlled trial to determine the safety and potential benefits of moderate intensity exercise in patients with hypertrophic cardiomyopathy. The investigators hypotheses are that exercise parameters derived from a baseline cardiopulmonary exercise test will target an appropriately safe level of exercise intensity that will not cause significant arrhythmias or exacerbate symptoms and that exercise training for 4 months will result in significant improvements in peak oxygen consumption and quality of life, with neutral effects on the clinical characteristics.


Condition Intervention
Cardiomyopathy, Hypertrophic
Behavioral: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Trial of Moderate Intensity Exercise Training in Hypertrophic Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in peak oxygen consumption [ Time Frame: At study initiation and 4 months later ] [ Designated as safety issue: No ]
    Cardiopulmonary exercise testing in combination with echocardiography will be performed at study initiation and termination (4 months).


Secondary Outcome Measures:
  • Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions. [ Time Frame: At study initiation and 4 months later ] [ Designated as safety issue: No ]
    Echocardiography and cardiac magnetic resonance imaging will be performed at study initiation and termination (4 months). Cardiac magnetic resonance imaging will only be performed in those who do not have implantable devices (ICDs).

  • Degree of left ventricular outflow obstruction. [ Time Frame: At study initiation and 4 months later ] [ Designated as safety issue: No ]
    Cardiopulmonary exercise testing in combination with echocardiography will be performed at study initiation and termination (4 months).

  • Systolic or diastolic function. [ Time Frame: At study initiation and 4 months later ] [ Designated as safety issue: No ]
    Echocardiography will be performed at study initiation and termination.

  • Scar volume by MRI [ Time Frame: At study initiation and 4 months later ] [ Designated as safety issue: No ]
    Cardiac magnetic resonance imaging (MRI) will be performed in all patients without implantable devices at study initiation and termination (4 months).

  • Stretch activation markers. [ Time Frame: At study initiation and 4 months later ] [ Designated as safety issue: No ]
    Blood will be drawn to evaluate stretch activation markers at study initiation and termination (4 months).

  • Quality of life indicators. [ Time Frame: At study initiation and 4 months later ] [ Designated as safety issue: No ]
    Quality of life questionnaires will be administered at study initiation and termination (4 months).


Estimated Enrollment: 128
Study Start Date: April 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Training
Participants in the exercise group will undergo 4 months of training, 4-7 days per week with a minimum of 20 minutes per day. The protocol will be custom designed in consultation with an exercise physiologist based on data from the initial cardiopulmonary stress test. Exercise regimen will begin at a low level of intensity then increase in duration and training intensity to a goal of 60 minutes a day and 80% of the heart rate reserve during the 1st month of the study protocol with maintenance of the program thereafter. There is no need to come to a participating site for actually doing the exercise regimen. No strength training or burst activity will be prescribed and all activities will fall well within the recommended national guidelines for recreational exercise.
Behavioral: Exercise training
4 months of exercise training that is custom-designed based on individual cardiopulmonary stress test data. Regimen starts at low intensity (60% of heart rate reserve) and frequency (20 minutes, 3 days per week) and increases with a goal of 80% of heart rate reserve and exercising 60 minutes 4-7 days per week.
No Intervention: Usual Activity
Participants in this group are not restricted in their activities. They simply are not guided in their physical activities by the study team. At the end of the 4 month study period, they will also receive an individualized exercise prescription for personal use.

Detailed Description:

The goal of this randomized clinical pilot trial is to establish the safety profile and potential benefits of moderate intensity exercise in patients with hypertrophic cardiomyopathy (HCM). Participation in competitive athletics is associated with an increased risk of sudden cardiac death (SCD) in individuals with structural heart disease, including HCM. This has appropriately led to the establishment of national guidelines based on expert opinion that discourage participation in high intensity competitive sports, burst exertion (e.g., sprinting), or isometric exercise (e.g., heavy lifting). Non-competitive, low to moderate intensity exercise is allowable, although many physicians and HCM patients are still understandably apprehensive. Data on the safety of a recreational exercise program, and how to gauge appropriate intensity level, are desperately needed so that HCM patients can reap the well established health benefits of regular physical activity. Limited, but compelling animal data suggest that moderate intensity exercise is not only safe, but may also prevent or even reverse cardiac hypertrophy, fibrosis, myocellular disarray, and apoptosis associated with HCM. There are no published studies on exercise in patients with HCM, although large clinical trials in heart failure have shown exercise training to be safe, to improve functional capacity and quality of life, and to lower cardiovascular mortality. The pilot randomized control trial proposed here is the first to determine the safety of moderate intensity exercise training and explore its potential benefits in patients with HCM.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years and ≤ 80.
  • Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy > 13 mm in any wall segment.
  • Time set aside specifically for aerobic exercise ≤ 30 minutes, ≤ 1 day per week in the previous 3 months.
  • Agreement to be a participant in the study protocol and willing/able to return for follow-up.

Exclusion Criteria:

  • History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).
  • Medically refractory left ventricular 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 mm Hg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).
  • Pregnancy.
  • ICD placement in last 3 months or scheduled.
  • Left ventricular systolic dysfunction (left ventricular ejection fraction < 55% by echocardiography).
  • Worsening clinical status in the last 3 months, advanced heart failure (New York Heart Association class IV symptoms) or angina (Canadian Cardiovascular Society class IV symptoms).
  • Life expectancy less than 12 months.
  • Inability to exercise due to orthopedic or other non-cardiovascular limitations.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127061

Contacts
Contact: Sara Saberi, MD 734-232-6346 saberis@umich.edu
Contact: Sharlene M Day, MD 734-615-7917 sday@umich.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Heidi Salisbury, BS, RN, MSN    650-736-7878      
Principal Investigator: Euan Ashley, MRCP, DPhil         
Sub-Investigator: Matthew Wheeler, MD, PhD         
Sub-Investigator: Aleks Pavlovic         
United States, Michigan
University of Michigan Cardiovascular Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Sara Saberi, MD    734-232-6346      
Contact: Sharlene Day, MD    734-615-7917    sday@umich.edu   
Principal Investigator: Sara Saberi, MD         
Principal Investigator: Sharlene M Day, MD         
Sub-Investigator: Gisela Mueller, MD         
Sponsors and Collaborators
University of Michigan
Stanford University
Investigators
Principal Investigator: Sara Saberi, MD University of Michigan
  More Information

No publications provided

Responsible Party: Sara Saberi, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01127061     History of Changes
Other Study ID Numbers: RESET-HCM
Study First Received: May 17, 2010
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Hypertrophic Cardiomyopathy
Exercise
Oxygen consumption

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

ClinicalTrials.gov processed this record on November 25, 2014