Physical Activity, Cardiac and Skeletal Muscle Energetics in Healthy Subjects and HFpEF Patients
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.
⁃ 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 screening visit and present for at least 1 month.
• Symptom(s) of HF requiring treatment with diuretic(s) for at least 30 days prior to screening
• Left ventricular ejection fraction (EF) \>=50% by echocardiography, MRI, CT or x-ray or nuclear ventriculography at screening visit or within prior 12 months.
• Patients with at least 1 of the following:
• HF hospitalization (defined as HF listed as the major reason for hospitalization and treatment with diuretics) or outpatient diuresis visit within 24 months prior to screening visit OR
• evidence of structural cardiac changes or elevated biomarkers. The structural changes are defined by at least 1 of the following echocardiography findings (any local measurement made during the screening epoch or within the 6 months prior to screening visit):
• Left Atrium (LA) enlargement defined by at least 1 of the following: LA width (diameter) ≥3.8 cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55 ml or LA volume index ≥29 ml/m2 ,
• Left Ventricular Hypertrophy (LVH) defined by septal thickness or posterior wall thickness ≥1.1 cm.
• The biomarker changes are defined as N terminal (NT)-proBNP \>200 pg/ml for patients not in atrial fibrillation (AF) or \>600 pg/ml for patients in AF on screening.
• Stable cardiovascular medical therapy for at least 30 days, defined as no addition or removal or major (\>100%) dose change of prescribed medications for the treatment of cardiovascular disease such as, but not limited to: Renin-Angiotensin-Aldosterone System (RAAS) antagonists, beta-blockers, or calcium channel blockers for hypertension.
• At Visit 1 (Screen 1), BMI of 30.0 - 50.0 kg/m2, inclusive.