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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure with Preserved Ejection Fraction | |||
| Healthy Volunteers |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference of daily activity measures based on accelerometry between HFpEF participants and adults without HFpEF. | Moderate to Vigorous Physical Activity (MVPA; minutes per day); Non-sedentary activity (i.e. sum of light activity and MVPA minutes per day. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of additional daily activity measures based on accelerometry between HFpEF participants and adults without HFpEF. | Sedentary Activity (minutes per day); | Up to 28 days |
| Rate of skeletal muscle phosphocreatine (PCr) decline during exercise normalized by work performed. |
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Inclusion Criteria:
All Participants:
Healthy Participants Only :
Heart Failure Participants Only:
Exclusion Criteria:
All participants
Participants are excluded from the study if any of the following criteria apply:
Prior/Concomitant Therapy:
Healthy [Non-HFpEF] Participants Only:
In addition, Healthy Participants presenting with any of the following will not be included in the study:
Heart Failure Participants Only:
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Individuals who are clinical patients of Johns Hopkins or an affiliate of Johns Hopkins.
Individuals who are clinical patients of the PI or co-investigators. Individuals who are not clinical patients of the PI or coinvestigators. Referral of individuals specifically for research purposes by treating clinicians not on the study team Prior Hopkins/Affiliates study participants Individuals who learn about the study through advertisements or peer/network recruiting
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| Name | Affiliation | Role |
|---|---|---|
| Robert G Weiss, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hosptial | Baltimore | Maryland | 21287 | United States |
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Difference between adults with and without HFpEF in rate of skeletal muscle [PCr] decline during exercise normalized by work performed. |
| Up to 28 days |