Physical Activity, Cardiac and Skeletal Muscle Energetics in Healthy Subjects and HFpEF Patients
Overview
- Phase
- Not Applicable
- Intervention
- Heart Failure with Preserved Ejection Fraction
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Sponsor
- Johns Hopkins University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Difference of daily activity measures based on accelerometry between HFpEF participants and adults without HFpEF.
- Status
- Active, not recruiting
- Last Updated
- 15 days ago
Overview
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.
Investigators
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 screening visit and present for at least 1 month.
Exclusion Criteria
- •All participants
- •Participants are excluded from the study if any of the following criteria apply:
- •Age \< 40 years or \> 85 years
- •A history of myocardial infarction, stroke, or transient ischemic attack, within 6 months of Screen 1 (Visit 1);
- •Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin); a subject is considered cured if there has been no evidence of cancer recurrence in the previous 5 years.
- •Participants with any contraindication to MRI scanning or an anatomical or pathological abnormality that would either preclude or tend to confound the analysis of study data, including the following:
- •History of severe claustrophobia impacting ability to perform MRI during the study
- •Implanted metallic objects contraindicated in MRI such as (pre-existing cardiac pacemakers, cerebral clips) or indwelling metallic projectiles;
- •Participants unable to fit within MRI scanner or follow instructions.
- •Fasting serum triglycerides ≥500 mg/dL (5.6 mmol/L) on current medications
Arms & Interventions
Heart Failure with Preserved Ejection Fraction
Healthy Volunteers
Outcomes
Primary Outcomes
Difference of daily activity measures based on accelerometry between HFpEF participants and adults without HFpEF.
Time Frame: Up to 28 days
Moderate to Vigorous Physical Activity (MVPA; minutes per day); Non-sedentary activity (i.e. sum of light activity and MVPA minutes per day.
Secondary Outcomes
- Rate of skeletal muscle phosphocreatine (PCr) decline during exercise normalized by work performed.(Up to 28 days)
- Difference of additional daily activity measures based on accelerometry between HFpEF participants and adults without HFpEF.(Up to 28 days)