Cardiomyopathy, HypertrophicRESET-HCMNCT01127061
Study of Exercise Training in Hypertrophic Cardiomyopathy
A study testing Exercise training in people with Cardiomyopathy, Hypertrophic, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiomyopathy, Hypertrophic
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, 48109
Stanford University
Stanford, California, 94305
About this study
Official title: A Randomized Trial of Moderate Intensity Exercise Training in Hypertrophic Cardiomyopathy
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.
Read the 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 peak VO2 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.
- Conditions
- Cardiomyopathy, Hypertrophic
- Being tested
- Exercise training
- Keywords
- Hypertrophic Cardiomyopathy, Exercise, Oxygen consumption
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study Enrollment and 4 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiomyopathy, HypertrophicStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Sara Saberi, University of Michigan
- Investigators
- Sara Saberi, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127061
- Sponsor's protocol ID
- RESET-HCM
- Acronym
- RESET-HCM
- Status last verified
- Oct 2018
- First submitted
- 17 May 2010
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28306757
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Moderate Intensity Exercise Training in Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01127061
- Acronym / sponsor ID
- RESET-HCM / RESET-HCM
- Conditions
- Cardiomyopathy, Hypertrophic
- Keywords
- Hypertrophic Cardiomyopathy, Exercise, Oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Apr 2010 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 peak VO2 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Behavioral: Exercise trainingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training4 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. | Behavioural | Exercise Training |
Primary outcome
Change in Peak Oxygen Consumption (Peak VO2)
Time frame: At study Enrollment and 4 months later
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28306757Saberi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Saberi, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Cardiomyopathy, Hypertrophic, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Oxygen Consumption (Peak VO2) (time frame: At study Enrollment and 4 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01127061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.