Cardiomyopathy, Hypertrophic Clinical Trial
Official title:
The Impact of Exercise-Induced Cardiac Remodeling on Myocardial Efficiency: A Multimodality Structural, Functional, and Metabolic Evaluation.
Verified date | March 2024 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | September 30, 2024 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria for Endurance Athletes: - 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). Inclusion Criteria for Healthy Volunteers: - 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: - 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 Inclusion Criteria for HCM Patients: - 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 Exclusion Criteria for HCM Patients: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Brigham and Women's Hospital, National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Left Ventricular Mass | Size of the left ventricle. | up to 2 weeks | |
Primary | Myocardial Metabolic Efficiency | The ratio of myocardial oxygen consumption to myocardial work. | up to 2 weeks | |
Secondary | Myocardial Blood Flow Reserve using PET | Difference in blood flow at rest and with exercise. | up to 2 weeks |
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