Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04580693
Other study ID # 2014P000781
Secondary ID K23HL136902
Status Active, not recruiting
Phase
First received
Last updated
Start date February 28, 2019
Est. completion date September 30, 2024

Study information

Verified date March 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital Brigham and Women's Hospital, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT00253682 - Effects of Highly Active Anti-Retroviral Therapy on Cardiovascular Health in Infants of HIV-Infected Mothers N/A
Recruiting NCT06034405 - Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Terminated NCT04222101 - Association of Insulin Resistance and FGF21 on Cardiac Function in Pediatric Dilated Cardiomyopathy N/A
Recruiting NCT05646056 - A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk
Completed NCT00692991 - Using Magnetic Resonance Imaging to Evaluate Heart Vessel Function After Angioplasty or Stent Placement Procedures N/A
Withdrawn NCT04905173 - Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic Cardiomyopathy N/A
Recruiting NCT03251287 - Nitrite in Hypertrophic Cardiomyopathy (HCM) Study Phase 1
Recruiting NCT01165749 - Exercise Study Including Patients With Hypertrophic Cardiomyopathy N/A
Recruiting NCT03057002 - UTSW HP [13-C] Pyruvate Injection in HCM
Recruiting NCT02696135 - The Chinese Hypertrophic Cardiomyopathy Study(CHCS)
Recruiting NCT03040947 - MRI Sequence and Imaging Protocol Development
Active, not recruiting NCT02417311 - Individualized Early Risk Assessment for Heart Diseases
Completed NCT03225001 - PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve N/A
Recruiting NCT05524077 - Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia N/A
Completed NCT04164732 - Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy Phase 2
Recruiting NCT06112743 - A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy Phase 4
Completed NCT00001871 - Study of Muscle Abnormalities in Patients With Specific Genetic Mutations N/A
Completed NCT00001459 - Analysis of Heart Muscle Function in Patients With Heart Disease and Normal Volunteers N/A
Completed NCT00005251 - Genetic Analysis of Familial Hypertrophic Cardiomyopathy N/A
Active, not recruiting NCT05556343 - A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy Phase 2