The Impact of Exercise-Induced Cardiac Remodeling on Myocardial Efficiency

NCT04580693 | Completed DMC FDA Drug

• 2 other identifiers: 2014P000781K23HL136902
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy, Hypertrophic

Keywords

Cardiomyopathy, Hypertrophic; Athletes, Endurance; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Myocardial Metabolic Efficiency

  The ratio of myocardial oxygen consumption to myocardial work.

  up to 2 weeks

Secondary Outcomes (1)

• Myocardial Blood Flow Reserve using PET

  up to 2 weeks

Other Outcomes (1)

• Left Ventricular Mass

  up to 2 weeks

Study Arms (3)

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.

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.

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.

Other: PET Scan

Interventions

PET Scan OTHER

PET scan using a tracer that is under a physician sponsored IND.

Endurance Athletes; Healthy Volunteers/Control; Hypertrophic Cardiomyopathy/HCM

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• hours of exercise per week without anticipated changes in exercise habits over study period
• Able to exercise on an upright bicycle ergometer

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood draws for analysis of blood for metabolic parameters (glucose, insulin, and free fatty-acid levels).

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 8, 2020
• Study Start: February 28, 2019
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)