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Clinical Trials/NCT04580693
NCT04580693
Completed
Not Applicable

The Impact of Exercise-Induced Cardiac Remodeling on Myocardial Efficiency: A Multimodality Structural, Functional, and Metabolic Evaluation.

Massachusetts General Hospital1 site in 1 country87 target enrollmentFebruary 28, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiomyopathy, Hypertrophic
Sponsor
Massachusetts General Hospital
Enrollment
87
Locations
1
Primary Endpoint
Myocardial Metabolic Efficiency
Status
Completed
Last Updated
11 months ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
February 28, 2019
End Date
June 9, 2022
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meagan Murphy Wasfy

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Myocardial Metabolic Efficiency

Time Frame: up to 2 weeks

The ratio of myocardial oxygen consumption to myocardial work.

Secondary Outcomes

  • Myocardial Blood Flow Reserve using PET(up to 2 weeks)

Study Sites (1)

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