RecruitingNCT04998877

Physical Activity, Cardiac and Skeletal Muscle Energetics in Healthy Subjects and HFpEF Patients


Sponsor

Johns Hopkins University

Enrollment

60 participants

Start Date

Aug 4, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

This research is being done to better understand the relationship between information collected by wearable devices and clinical measurements in people with heart failure with preserved ejection fraction (HFpEF) and others without HFpEF. This is an observational study with no study intervention or randomization. Participants will undergo baseline history and physical, 12-lead EKG, laboratory studies of blood/serum/urine, echocardiography, activity questionnaire, 6 minute walk test, and placement of wearable devices to be worn for up to 14 days (activity monitors, EKG monitor and continuous glucose monitor). Participants will return after \~14 days of wearing the devices and repeat of physical examination, 12-lead EKG, 6 minute walk test, activity questionnaire. Additionally, participants will undergo magnetic resonance imaging (MRI) of their leg with exercise, cardiopulmonary exercise testing (CPET) and, for those who qualify, magnetic resonance imaging (MRI) of their heart with exercise.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study uses specialized MRI and exercise tests to examine how physical activity affects heart and muscle energy production in both healthy individuals with obesity and in patients with a form of heart failure called HFpEF (heart failure with preserved ejection fraction), where the heart squeezes normally but doesn't fill properly. **You may be eligible if...** - You are 40–85 years old - You have a BMI between 30 and 50 - Healthy participants must have no history of diabetes, heart failure, heart attack, or major vascular disease - Heart failure participants must have a confirmed HFpEF diagnosis with symptoms for at least 1 month, on diuretic treatment for at least 30 days, and a preserved ejection fraction (≥50%) **You may NOT be eligible if...** - You have had a heart attack, stroke, or TIA within the past 6 months - You have an active cancer not in remission for 5+ years - You have metal implants or severe claustrophobia preventing MRI - You have very high triglycerides or LDL cholesterol on current medications - You have had weight loss surgery or taken weight loss drugs in the past 6 months - Heart failure patients: you have infiltrative cardiomyopathy, severe valve disease, significant coronary artery disease, or kidney function below a certain threshold Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Johns Hopkins Hosptial

Baltimore, Maryland, United States

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NCT04998877


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