Cardiomyopathy, HypertrophicNCT04580693
The Impact of Exercise-Induced Cardiac Remodeling on Myocardial Efficiency
An observational study of Cardiomyopathy, Hypertrophic, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is being conducted to find out how heart function and energy use differ among healthy endurance athletes, individuals who do not exercise regularly, and patients with hypertrophic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cardiomyopathy, Hypertrophic
- What is being tested?
- PET Scan
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 9 Jun 2022
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Endurance Athletes: A collegiate rowing team or invitation to participate from local endurance type athletic clubs. (i.e. running clubs, rowing teams, etc.) HCM Patients: MGH Hypertrophic Cardiomyopathy Program's database, the Research Patient Data Registry (RPDR), and through the BWH Hypertrophic Cardiomyopathy Program's patient panel. Also RALLY. Healthy Control/Volunteers: Partners RALLY (research ally) website.
Who may be able to join
- Age ≥ 18-60
- Official participation in a collegiate varsity rowing team OR participation in competitive endurance athletics (defined as >= 10 hours of exercise training per week with the majority dedicated to endurance activities (i.e. cycling, rowing, running).
- Age ≥ 18-60
- 0-5 hours of exercise per week without anticipated changes in exercise habits over study period
- Able to exercise on an upright bicycle ergometer
- Exclusion Criteria for Endurance Athletes and Healthy Volunteers:
Show all 12Show fewer
- Known medical disease (including but not limited to known cardiac or pulmonary disease, diabetes or contraindications to exercise testing such as uncontrolled cardiac arrhythmia, excessive blood pressure of more than 200/100 mmHg at rest, active exacerbation of congestive heart failure or reactive airways disease).
- Pregnancy
- Established HCM diagnosis as per above (20 subjects)
- Age ≥ 18-50
- No anticipated changes to baseline exercise program (if any) over the study period
- Able to exercise on an upright bicycle ergometer
Who cannot join
- Obstructive LVOT gradient > 30 mmHg, at rest or with provocation.
- Reduced LVEF < 53%.
- NYHA class III or IV heart failure symptoms.
- History of sudden cardiac death or hemodynamically significant ventricular tachycardia.
- History of unexplained syncope.
- Having a Class I or IIa AHA/ACC indication for ICD placement without an ICD
- Known medical disease (including but not limited to known cardiac or pulmonary disease other than HCM, diabetes, or contraindications to exercise testing such as uncontrolled cardiac arrhythmia, excessive blood pressure of more than 200/100 mmHg at rest, active exacerbation of congestive heart failure or reactive airways disease).
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Impact of Exercise-Induced Cardiac Remodeling on Myocardial Efficiency: A Multimodality Structural, Functional, and Metabolic Evaluation.
This research study is being conducted to find out how heart function and energy use differ among healthy endurance athletes, individuals who do not exercise regularly, and patients with hypertrophic cardiomyopathy. The research study involves taking part in a cardiopulmonary exercise test (CPET), two positron emission tomography (PET) scans, an echocardiogram, and blood draws. The study will consist of a total of three visits scheduled over a maximum of two weeks. By determining how heart function and energy use differ between our three groups of healthy endurance athletes, individuals who do not exercise regularly, and patients with hypertrophic cardiomyopathy, the investigators hope to have this work translate into a novel clinical tool for differentiating pathologic changes of the heart from physiological changes in heart. This is otherwise known as "gray-zone" left ventricular hypertrophy, or enlargement of the left ventricle.
Read the detailed description
The investigators anticipate that by defining the myocardial metabolic profiles of exercise-induced left ventricular hypertrophy (EI-LVH) and hypertrophic cardiomyopathy (HCM), we will determine if these differ sufficiently to distinguish these two forms of LVH. Because HCM causes sudden death with physical activity, it is critically important to determine the etiology of undifferentiated "gray zone" LVH in the athlete presenting for medical evaluation, and existing mechanisms of assessing myocardial structure and function are not universally adequate. The investigators anticipate that the work may translate into a novel clinical tool for differentiating pathology from physiology in "gray-zone" LVH. The complementary mechanistic goal of this study is to combine comprehensive evaluations of myocardial functional parameters and metabolism to better understand the link between function and metabolism and, ultimately, the biological mechanisms of EI-LVH and LVH due to HCM. There are three specific aims to the research study. The first specific aim is to define the relationships between changes in myocardial metabolic efficiency (MME) and changes in myocardial mechanics that accompany EI-LVH. The second is to establish and compare myocardial metabolic profiles of EI-LVH and HCM. The third is to analyze a subset of the endurance athlete subjects to determine the impact of aerobic exercise training on MME over a 90-day period.
The study will employ a mixed study design. The study is a cross-sectional design but will analyze a subset of endurance athletes longitudinally with repeated measures after 90 days from the first three study visits.
For the cross sectional design, the first study visit will be at Massachusetts General Hospital and will involve a cardiopulmonary exercise test (CPET) on an upright bicycle, with blood sampling before the CPET at rest, and after exercise. Study visits two and three will follow the same protocol. Both study visits two and three will occur at Brigham and Women's Hospital and will involve an echocardiogram and a positron emission tomography (PET) scan. Both visits will include blood sampling at rest, and then either the resting PET scan or a PET scan after acute exercise provocation on a supine bicycle. Study visits two and three will occur on two sequential mornings.
- Conditions
- Cardiomyopathy, Hypertrophic
- Being tested
- PET Scan
- Keywords
- Cardiomyopathy, Hypertrophic, Athletes, Endurance, Healthy Volunteers
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ScanOther
PET scan using a tracer that is under a physician sponsored IND.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers/Control | Age and body surface area (BSA) matched volunteers who are sedentary or normally active. Normally active is defined as less than 5 hours of exercise per week. Healthy volunteer subjects must be able to exercise on an upright bicycle ergometer and be between the ages of 18-50. Receives: Other: PET Scan | |
| Hypertrophic Cardiomyopathy/HCM | HCM subjects are patients that are age and BSA-matched with the athletes who then have an established clinical diagnosis of HCM without left ventricular (LV) outflow tract obstruction. There can be no anticipated changes to baseline exercise program (if any) over the study period. HCM subjects must be able to exercise on an upright bicycle ergometer and be between the ages of 18-50. Receives: Other: PET Scan | |
| Endurance Athletes | Official participation in a collegiate athletic varsity rowing team OR participation in competitive endurance athletics. Competitive endurance athletics is defined as greater than or equal to 10 hours of exercise training per week with the majority dedicated to endurance activities such as cycling, rowing, or running. Endurance athlete subjects must be able to exercise on an upright bicycle ergometer and be between the ages of 18-50. Receives: Other: PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Metabolic Efficiency
The ratio of myocardial oxygen consumption to myocardial work.
Measured: up to 2 weeks
Secondary outcomes (1)
Myocardial Blood Flow Reserve using PET
Difference in blood flow at rest and with exercise.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start28 Feb 2019
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, HypertrophicStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meagan Murphy Wasfy, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580693
- Sponsor's protocol ID
- 2014P000781
- Other IDs
- K23HL136902
- Status last verified
- May 2025
- First submitted
- 28 Sep 2020
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Exercise-Induced Cardiac Remodeling on Myocardial Efficiency: A Multimodality Structural, Functional, and Metabolic Evaluation.
- ClinicalTrials.gov ID
- NCT04580693
- Acronym / sponsor ID
- 2014P000781
- Conditions
- Cardiomyopathy, Hypertrophic
- Keywords
- Cardiomyopathy, Hypertrophic, Athletes, Endurance, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 8 Oct 2020 (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.
This research study is being conducted to find out how heart function and energy use differ among healthy endurance athletes, individuals who do not exercise regularly, and patients with hypertrophic cardiomyopathy. The research study involves taking part in a cardiopulmonary exercise test (CPET), two positron emission tomography (PET) scans, an echocardiogram, and blood draws. The study will consist of a total of three visits scheduled over a maximum of two weeks. By determining how heart function and energy use differ between our three groups of healthy endurance athletes, individuals who do not exercise regularly, and patients with hypertrophic cardiomyopathy, the investigators hope to have this work translate into a novel clinical tool for differentiating pathologic changes of the heart from physiological changes in heart. This is otherwise known as "gray-zone" left ventricular hypertrophy, or enlargement of the left ventricle.
Detailed description
The investigators anticipate that by defining the myocardial metabolic profiles of exercise-induced left ventricular hypertrophy (EI-LVH) and hypertrophic cardiomyopathy (HCM), we will determine if these differ sufficiently to distinguish these two forms of LVH. Because HCM causes sudden death with physical activity, it is critically important to determine the etiology of undifferentiated "gray zone" LVH in the athlete presenting for medical evaluation, and existing mechanisms of assessing myocardial structure and function are not universally adequate. The investigators anticipate that the work may translate into a novel clinical tool for differentiating pathology from physiology in "gray-zone" LVH. The complementary mechanistic goal of this study is to combine comprehensive evaluations of myocardial functional parameters and metabolism to better understand the link between function and metabolism and, ultimately, the biological mechanisms of EI-LVH and LVH due to HCM. There are three specific aims to the research study. The first specific aim is to define the relationships between changes in myocardial metabolic efficiency (MME) and changes in myocardial mechanics that accompany EI-LVH. The second is to establish and compare myocardial metabolic profiles of EI-LVH and HCM. The third is to analyze a subset of the endurance athlete subjects to determine the impact of aerobic exercise training on MME over a 90-day period.
The study will employ a mixed study design. The study is a cross-sectional design but will analyze a subset of endurance athletes longitudinally with repeated measures after 90 days from the first three study visits.
For the cross sectional design, the first study visit will be at Massachusetts General Hospital and will involve a cardiopulmonary exercise test (CPET) on an upright bicycle, with blood sampling before the CPET at rest, and after exercise. Study visits two and three will follow the same protocol. Both study visits two and three will occur at Brigham and Women's Hospital and will involve an echocardiogram and a positron emission tomography (PET) scan. Both visits will include blood sampling at rest, and then either the resting PET scan or a PET scan after acute exercise provocation on a supine bicycle. Study visits two and three will occur on two sequential mornings.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers/Control | – | Other: PET ScanAge and body surface area (BSA) matched volunteers who are sedentary or normally active. Normally active is defined as less than 5 hours of exercise per week. Healthy volunteer subjects must be able to exercise on an upright bicycle ergometer and be between the ages of 18-50. |
| Hypertrophic Cardiomyopathy/HCM | – | Other: PET ScanHCM subjects are patients that are age and BSA-matched with the athletes who then have an established clinical diagnosis of HCM without left ventricular (LV) outflow tract obstruction. There can be no anticipated changes to baseline exercise program (if any) over the study period. HCM subjects must be able to exercise on an upright bicycle ergometer and be between the ages of 18-50. |
| Endurance Athletes | – | Other: PET ScanOfficial participation in a collegiate athletic varsity rowing team OR participation in competitive endurance athletics. Competitive endurance athletics is defined as greater than or equal to 10 hours of exercise training per week with the majority dedicated to endurance activities such as cycling, rowing, or running. Endurance athlete subjects must be able to exercise on an upright bicycle ergometer and be between the ages of 18-50. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Endurance Athletes: A collegiate rowing team or invitation to participate from local endurance type athletic clubs. (i.e. running clubs, rowing teams, etc.) HCM Patients: MGH Hypertrophic Cardiomyopathy Program's database, the Research Patient Data Registry (RPDR), and through the BWH Hypertrophic Cardiomyopathy Program's patient panel. Also RALLY. Healthy Control/Volunteers: Partners RALLY (research ally) website.
Key inclusion criteria (12 listed)
- Age ≥ 18-60
- Official participation in a collegiate varsity rowing team OR participation in competitive endurance athletics (defined as >= 10 hours of exercise training per week with the majority dedicated to endurance activities (i.e. cycling, rowing, running).
- Age ≥ 18-60
- 0-5 hours of exercise per week without anticipated changes in exercise habits over study period
- Able to exercise on an upright bicycle ergometer
Key exclusion criteria (8 listed)
- Obstructive LVOT gradient > 30 mmHg, at rest or with provocation.
- Reduced LVEF < 53%.
- NYHA class III or IV heart failure symptoms.
- History of sudden cardiac death or hemodynamically significant ventricular tachycardia.
- History of unexplained syncope.
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 |
|---|---|---|
| PET ScanPET scan using a tracer that is under a physician sponsored IND. | Other | Endurance Athletes, Healthy Volunteers/Control, Hypertrophic Cardiomyopathy/HCM |
Primary outcome
Myocardial Metabolic Efficiency
Time frame: up to 2 weeks
The ratio of myocardial oxygen consumption to myocardial work.
1 secondary outcome
Myocardial Blood Flow Reserve using PET
Time frame: up to 2 weeks
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 16 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, Hypertrophic, run by Massachusetts General Hospital 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 12 inclusion and 8 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 16 May 2025. 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?
Myocardial Metabolic Efficiency (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.