Physical Activity, Cardiac and Skeletal Muscle Energetics in Healthy Subjects and HFpEF Patients
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria: All Participants: * Women and men between the ages of 40 and 85 years, inclusive, at the Screening visit. * Women of childbearing potential require a negative pregnancy test. * Participants who are willing and able to comply with all scheduled visits, laboratory tests, lifestyle considerations, and other study procedures. * Capable of giving signed informed consent, which includes willingness to be compliant with the requirements and restrictions listed in the informed consent document and in this protocol. Healthy Participants Only : * Healthy participants with no history of diabetes mellitus, or significant heart or vascular disease, including a history of heart failure, myocardial infarction, revascularization or positive exercise tolerance test for ischemia (if previously performed). * BMI of 30.0 - 50.0 kg/m2, inclusive Heart Failure Participants Only: * Previous clinical diagnosis of heart failure with New York Heart Association (NYHA) Class II-IV symptoms at