Physical Activity, Cardiac and Skeletal Muscle Energetics in Healthy Subjects and HFpEF Patients
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Johns Hopkins University
- Study ID
- NCT04998877
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 85 Years
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- First listed
- Aug 10, 2021
- Start date
- Aug 4, 2021
- Status verified
- Jul 2026
- Primary completion
- Dec 30, 2027
- Completion
- Dec 30, 2027
Study Design
- Enrollment
- 60 participants (estimated)
Arms
- Arm: Heart Failure with Preserved Ejection Fraction
- Arm: Healthy Volunteers
Primary Outcome Measure
Difference of daily activity measures based on accelerometry between HFpEF participants and adults without HFpEF. [ Time Frame: Up to 28 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins Hosptial | Baltimore | Maryland | 21287 | - |
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