Hypertrophic CardiomyopathyNCT03335332
High Intensity Exercise for Increasing Fitness in Patients With Hypertrophic Cardiomyopathy
A study testing High intensity exercise and Moderate intensity exercise in people with Hypertrophic Cardiomyopathy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Although current clinical guidelines stipulate that patients with hypertrophic cardiomyopathy should not partake in high intensity exercise (HIE) or competitive sport due to safety concerns, there is no clear evidence to support this notion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- High intensity exercise and Moderate intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male and female patients aged 18 - 80 years old
- Diagnosed HCM defined by the presence of unexplained left-ventricular hypertrophy with end-diastolic wall thickness ≥ 15 mm on 2D echocardiography or wall thickness between 13 and 15 mm along with at least one other piece of evidence of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
Who cannot join
- A history of exercise-induced syncope or arrhythmias (ventricular tachycardia; sustained or non-sustained)
- Left ventricular outflow obstruction (≥ 50 mm Hg at rest)
- Less than 3 months post septal reduction therapy (surgery or catheter based intervention)
- Pregnancy
- Worsening clinical status or advanced heart failure (New York Heart Association class IV symptoms)
- A hypotensive responsive to exercise (an increase in exercise systolic BP throughout the exercise test of < 20mmHg compared with resting values, or an initial increase in systolic BP > 20mmHg with a subsequent fall by peak exercise of > 20mmHg, or a continuous decrease in systolic BP throughout the test of > 20mmHg, compared with baseline BP)
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- Left ventricular systolic dysfunction (left ventricular ejection fraction < 55 % by echocardiography)
- Coronary artery disease as evidenced by prior myocardial infarction or angina
- Cerebrovascular disease as evidenced by prior transient ischemic attack or stroke
- A chronic orthopaedic injury which limits the ability to exercise
- Subjects unable to speak English will not be recruited because of the complex experimental studies and the need for precise communication between the volunteers and the research staff to ensure safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231
About this study
Official title: Efficacy of High Intensity Exercise (HIE) for Increasing Cardiorespiratory Fitness in Patients With Hypertrophic Cardiomyopathy (HCM)
Although current clinical guidelines stipulate that patients with hypertrophic cardiomyopathy should not partake in high intensity exercise (HIE) or competitive sport due to safety concerns, there is no clear evidence to support this notion. In fact, two exercise training interventions in this population indicates that regular moderate to vigorous intensity exercise is efficacious for improving exercise capacity and cardiorespiratory fitness, and does not increase arrhythmia burden or adverse events. Moreover, moderate intensity exercise and HIE training significantly increases cardiorespiratory fitness in patients with cardiac disease. Such improvements are associated with substantial reductions in cardiovascular mortality and might outweigh the risk of adverse events in patients with hypertrophic cardiomyopathy (HCM). Having a genetic cardiomyopathy does not grant immunity against lifestyle related cardiometabolic diseases and inactivity is rife in HCM patients likely due to misinformation/education. It is therefore paramount to further explore the benefits of regular moderate intensity exercise and HIE in patients with HCM for proper therapeutic management of the condition.
Read the detailed description
Regular exercise reduces the risk of all-cause and cardiovascular mortality in the general population. Specifically, higher cardiorespiratory fitness is associated with a 10 - 20 % reduction in mortality risk for every 1 MET (metabolic equivalent tasks) improvement in fitness. A high degree of fitness is also protective against the development of heart failure and exercise training has become the standard of care for most patients with cardiovascular disease to improve functional capacity, and reduce morbidity and mortality. However, hypertrophic cardiomyopathy, the most common inherited cardiovascular disease, may be an exception. For more than 30 years, hypertrophic cardiomyopathy (HCM) has been identified as the most common cause of death in young athletes, and patients with HCM are excluded from participation in competitive sports. The fear of provocation of sudden cardiac death has often been extended to non-competitive athletic activities in such patients, though there is a distinct lack of evidence about the safety of exercise in this population. A recent multicenter clinical trial provided evidence that moderate intensity exercise (MIE) may be safe in this population, though the increase in fitness with this training paradigm was modest. Alternatively, an extensive series of reviews published over the last five years advocate for high intensity interval training (HIIT) as an efficacious stimulus for increasing cardiorespiratory fitness in clinical adult populations, including those with heart failure. While a pilot investigation and preliminary findings suggest that moderate to vigorous intensity exercise may be safe and efficacious in patients with HCM, and even protective in animal models, there is no Level A or B evidence comparing the efficacy or safety of MIE and high intensity exercise (HIE) training in this patient population to guide exercise prescription. Therefore, the primary purpose of this exercise trial is to compare the efficacy and safety of supervised MIE and HIE training in adults with HCM. Specific aims and hypotheses of the project are as follows:
Aim 1: Compare the efficacy of a high intensity and moderate intensity exercise intervention to improve cardiorespiratory fitness and functional diastolic reserve in patients with HCM.
- Primary hypothesis: HIE will result in greater increases in maximal oxygen uptake (V̇O2max) than MIE in patients with HCM.
- Secondary hypothesis: HIE will improve stroke volume reserve to a greater degree than MIE in patients with HCM.
Aim 2: To evaluate the safety of HIE training in patients with HCM.
- Hypothesis: Regular exercise training of a high or moderate intensity will be safe (no serious adverse events) in this patient population. Specifically, it is hypothesised that HIE will not increase arrhythmia burden in patients with HCM.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- High intensity exercise, Moderate intensity exercise
- Keywords
- High intensity exercise, Cardiorespiratory fitness, Stroke volume reserve, Arrhythmia burden
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity exerciseBehavioural
The exercise groups will receive identical exercise prescription for the first two months of the intervention, after which the HIE group will incorporate HIIT in their exercise regimen. The reason for this approach is to include a period of general conditioning and progressively increase intensity prior to submitting volunteers to HIE. This approach considers participant safety as arrhythmias may be uncovered during the first two months of MIE training. It will also improve participant compliance by increasing exercise self-efficacy and confidence prior to commencing HIIT.
Moderate intensity exerciseBehavioural
A training program will be developed individually for each subject with the goal of increasing duration and intensity consistent with exercise training principles. Workouts will vary with respect to mode (walk, cycle) and duration (30 - 60 minutes). Each subject will be assigned an exercise physiologist and a heart rate monitor so that each session can be tracked and recorded. The first few exercise training sessions in both exercise groups (MIE and HIE) will supervised at our hospital based fitness centre until the subject is confident to complete the training independently.
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise | Experimental | A training program will be developed individually for each subject with the goal of increasing duration and intensity consistent with exercise training principles. Workouts will vary with respect to mode (walk, cycle) and duration (30 - 60 minutes). Each subject will be assigned an exercise physiologist and a heart rate monitor so that each session can be tracked and recorded. The first few exercise training sessions will supervised at our hospital based fitness centre until the subject is confident to complete the training independently. All HIIT sessions will be supervised over the intervention. Receives: Behavioral: High intensity exercise |
| Moderate intensity exercise | Active comparator | Not described Receives: Behavioral: Moderate intensity exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
Change in maximal oxygen uptake (V̇O2max)
Measured: Five months
Secondary outcomes (3)
Functional diastolic reserve
Change in stroke volume reserve
Measured: Five months
Safety - Number of adverse events
Adverse events during the study will be recorded
Measured: Ten months
Safety - Number of arrhythmic events
Number of arrhythmic events will be assessed by an implantable loop recorder
Measured: Ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start31 Jan 2018
- Primary completion26 Jul 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG, American College of Sports Medicine, American Heart Association
- Responsible party
- Principal investigator, Benjamin Levine, University of Texas Southwestern Medical Center
- Investigators
- Benjamin D Levine, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335332
- Sponsor's protocol ID
- STU 072017-048
- Status last verified
- Feb 2023
- First submitted
- 19 Sep 2017
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MacNamara JP, Dias KA, Hearon CM Jr, Ivey E, Delgado VA, Saland S, Samels M, Hieda M, Turer AT, Link MS, Sarma S, Levine BD. Randomized Controlled Trial of Moderate- and High-Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy: Effects on Fitness and Cardiovascular Response to Exercise. J Am Heart Assoc. 2023 Oct 17;12(20):e031399. doi: 10.1161/JAHA.123.031399. Epub 2023 Oct 13.
PubMed 37830338
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Intensity Exercise (HIE) for Increasing Cardiorespiratory Fitness in Patients With Hypertrophic Cardiomyopathy (HCM)
- ClinicalTrials.gov ID
- NCT03335332
- Acronym / sponsor ID
- STU 072017-048
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- High intensity exercise, Cardiorespiratory fitness, Stroke volume reserve, Arrhythmia burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG, American College of Sports Medicine, American Heart Association
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although current clinical guidelines stipulate that patients with hypertrophic cardiomyopathy should not partake in high intensity exercise (HIE) or competitive sport due to safety concerns, there is no clear evidence to support this notion. In fact, two exercise training interventions in this population indicates that regular moderate to vigorous intensity exercise is efficacious for improving exercise capacity and cardiorespiratory fitness, and does not increase arrhythmia burden or adverse events. Moreover, moderate intensity exercise and HIE training significantly increases cardiorespiratory fitness in patients with cardiac disease. Such improvements are associated with substantial reductions in cardiovascular mortality and might outweigh the risk of adverse events in patients with hypertrophic cardiomyopathy (HCM). Having a genetic cardiomyopathy does not grant immunity against lifestyle related cardiometabolic diseases and inactivity is rife in HCM patients likely due to misinformation/education. It is therefore paramount to further explore the benefits of regular moderate intensity exercise and HIE in patients with HCM for proper therapeutic management of the condition.
Detailed description
Regular exercise reduces the risk of all-cause and cardiovascular mortality in the general population. Specifically, higher cardiorespiratory fitness is associated with a 10 - 20 % reduction in mortality risk for every 1 MET (metabolic equivalent tasks) improvement in fitness. A high degree of fitness is also protective against the development of heart failure and exercise training has become the standard of care for most patients with cardiovascular disease to improve functional capacity, and reduce morbidity and mortality. However, hypertrophic cardiomyopathy, the most common inherited cardiovascular disease, may be an exception. For more than 30 years, hypertrophic cardiomyopathy (HCM) has been identified as the most common cause of death in young athletes, and patients with HCM are excluded from participation in competitive sports. The fear of provocation of sudden cardiac death has often been extended to non-competitive athletic activities in such patients, though there is a distinct lack of evidence about the safety of exercise in this population. A recent multicenter clinical trial provided evidence that moderate intensity exercise (MIE) may be safe in this population, though the increase in fitness with this training paradigm was modest. Alternatively, an extensive series of reviews published over the last five years advocate for high intensity interval training (HIIT) as an efficacious stimulus for increasing cardiorespiratory fitness in clinical adult populations, including those with heart failure. While a pilot investigation and preliminary findings suggest that moderate to vigorous intensity exercise may be safe and efficacious in patients with HCM, and even protective in animal models, there is no Level A or B evidence comparing the efficacy or safety of MIE and high intensity exercise (HIE) training in this patient population to guide exercise prescription. Therefore, the primary purpose of this exercise trial is to compare the efficacy and safety of supervised MIE and HIE training in adults with HCM. Specific aims and hypotheses of the project are as follows:
Aim 1: Compare the efficacy of a high intensity and moderate intensity exercise intervention to improve cardiorespiratory fitness and functional diastolic reserve in patients with HCM.
- Primary hypothesis: HIE will result in greater increases in maximal oxygen uptake (V̇O2max) than MIE in patients with HCM.
- Secondary hypothesis: HIE will improve stroke volume reserve to a greater degree than MIE in patients with HCM.
Aim 2: To evaluate the safety of HIE training in patients with HCM.
- Hypothesis: Regular exercise training of a high or moderate intensity will be safe (no serious adverse events) in this patient population. Specifically, it is hypothesised that HIE will not increase arrhythmia burden in patients with HCM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise | Experimental | Behavioral: High intensity exerciseA training program will be developed individually for each subject with the goal of increasing duration and intensity consistent with exercise training principles. Workouts will vary with respect to mode (walk, cycle) and duration (30 - 60 minutes). Each subject will be assigned an exercise physiologist and a heart rate monitor so that each session can be tracked and recorded. The first few exercise training sessions will supervised at our hospital based fitness centre until the subject is confident to complete the training independently. All HIIT sessions will be supervised over the intervention. |
| Moderate intensity exercise | Active comparator | Behavioral: Moderate intensity exercise |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients aged 18 - 80 years old
- Diagnosed HCM defined by the presence of unexplained left-ventricular hypertrophy with end-diastolic wall thickness ≥ 15 mm on 2D echocardiography or wall thickness between 13 and 15 mm along with at least one other piece of evidence of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
Key exclusion criteria (11 listed)
- A history of exercise-induced syncope or arrhythmias (ventricular tachycardia; sustained or non-sustained)
- Left ventricular outflow obstruction (≥ 50 mm Hg at rest)
- Less than 3 months post septal reduction therapy (surgery or catheter based intervention)
- Pregnancy
- Worsening clinical status or advanced heart failure (New York Heart Association class IV symptoms)
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 |
|---|---|---|
| High intensity exerciseThe exercise groups will receive identical exercise prescription for the first two months of the intervention, after which the HIE group will incorporate HIIT in their exercise regimen. The reason for this approach is to include a period of general conditioning and progressively increase intensity prior to submitting volunteers to HIE. This approach considers participant safety as arrhythmias may be uncovered during the first two months of MIE training. It will also improve participant compliance by increasing exercise self-efficacy and confidence prior to commencing HIIT. | Behavioural | High intensity exercise |
| Moderate intensity exerciseA training program will be developed individually for each subject with the goal of increasing duration and intensity consistent with exercise training principles. Workouts will vary with respect to mode (walk, cycle) and duration (30 - 60 minutes). Each subject will be assigned an exercise physiologist and a heart rate monitor so that each session can be tracked and recorded. The first few exercise training sessions in both exercise groups (MIE and HIE) will supervised at our hospital based fitness centre until the subject is confident to complete the training independently. | Behavioural | Moderate intensity exercise |
Primary outcome
Cardiorespiratory fitness
Time frame: Five months
Change in maximal oxygen uptake (V̇O2max)
3 secondary outcomes
Functional diastolic reserve
Time frame: Five months
Safety - Number of adverse events
Time frame: Ten months
Safety - Number of arrhythmic events
Time frame: Ten months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 37830338MacNamara JP, Dias KA, Hearon CM Jr, Ivey E, Delgado VA, Saland S, Samels M, Hieda M, Turer AT, Link MS, Sarma S, Levine BD. Randomized Controlled Trial of Moderate- and High-Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy: Effects on Fitness and Cardiovascular Response to Exercise. J Am Heart Assoc. 2023 Oct 17;12(20):e031399. doi: 10.1161/JAHA.123.031399. Epub 2023 Oct 13.
- Individual participant dataSharing planned: No
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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.
Benjamin D Levine, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity exercise and Moderate intensity exercise in people with Hypertrophic Cardiomyopathy, run by University of Texas Southwestern Medical Center at 1 site 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 2 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 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiorespiratory fitness (time frame: Five months). 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 NCT03335332, 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 28 Feb 2023.