Study of Exercise Training in Hypertrophic Cardiomyopathy

NCT01127061 | Completed Results DMC

• 1 other identifier: RESET-HCM
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

Brief Summary

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 (peak VO2) and quality of life, with neutral effects on the clinical characteristics.

Conditions

Cardiomyopathy, Hypertrophic

Keywords

Hypertrophic Cardiomyopathy; Exercise; Oxygen consumption

Outcome Measures

Primary Outcomes (1)

• Change in Peak Oxygen Consumption (Peak VO2)

  Cardiopulmonary exercise testing was performed at study enrollment and termination (4 months apart). Peak VO2 was measured at each time point in each subject and change in peak VO2 over time was calculated. The change in Peak VO2 was compared between the study arms.

  At study Enrollment and 4 months later

Other Outcomes (12)

• Change in Quality of Life

  At study enrollment and 4 months later

• Change in Concentration of Brain Natriuretic Peptide (BNP)

  At study enrollment and 4 months later

• Change in Scar Volume

  At study enrollment and 4 months later

Study Arms (2)

Exercise Training

EXPERIMENTAL

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 70% 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

Usual Activity

NO INTERVENTION

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.

Interventions

Exercise training BEHAVIORAL

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 70% of heart rate reserve and exercising 60 minutes 4-7 days per week.

Exercise Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 80.
• Diagnosis of HCM, defined by the presence of unexplained left-ventricular hypertrophy \> 13 mm in any wall segment.
• 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 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.
• Implantable Cardioverter-Defibrillator (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.
• Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study.

Sponsors & Collaborators

• University of Michigan: lead
• Stanford University: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Saberi S, Wheeler M, Bragg-Gresham J, Hornsby W, Agarwal PP, Attili A, Concannon M, Dries AM, Shmargad Y, Salisbury H, Kumar S, Herrera JJ, Myers J, Helms AS, Ashley EA, Day SM. Effect of Moderate-Intensity Exercise Training on Peak Oxygen Consumption in Patients With Hypertrophic Cardiomyopathy: A Randomized Clinical Trial. JAMA. 2017 Apr 4;317(13):1349-1357. doi: 10.1001/jama.2017.2503.

  PMID: 28306757 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Potential for sampling bias. Modest effect size of exercise training. Not powered to assess safety. Not possible to blind patients to treatment assignment. Prescription only incorporated moderate-intensity aerobic exercise in adult patients.

Results Point of Contact

• Title: Dr. Sara Saberi, MD, MS
• Organization: University of Michigan School of Medicine

saberis@med.umich.edu

734-764-4500

Study Officials

• Sara Saberi, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator who randomized participants was blinded to participant PHI. Investigators who interpreted all data and assessed outcomes were masked to randomization status.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 20, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2016
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2018-10

Locations

US (2)