Physical Activity, Cardiac and Skeletal Muscle Energetics in Healthy Subjects and HFpEF Patients

NCT04998877 | Active Not Recruiting

• 1 other identifier: IRB00270339
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Difference of additional daily activity measures based on accelerometry between HFpEF participants and adults without HFpEF.

  Up to 28 days

• Rate of skeletal muscle phosphocreatine (PCr) decline during exercise normalized by work performed.

  Up to 28 days

Study Arms (2)

Heart Failure with Preserved Ejection Fraction

Healthy Volunteers

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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):

You may not qualify if:

• 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
• Fasting LDL-C ≥190 mg/dL (4.9 mmol/L) on current medications
• Prior/Concomitant Therapy:
• Use of prior/concomitant weight loss pharmacotherapy or weight loss surgery within the prior six months.
• Healthy \[Non-HFpEF\] Participants Only:
• In addition, Healthy Participants presenting with any of the following will not be included in the study:

Sponsors & Collaborators

• Johns Hopkins University: lead
• Pfizer: collaborator

Study Sites (1)

Johns Hopkins Hosptial

Baltimore, Maryland, 21287, United States

Location

Study Officials

• Robert G Weiss, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 10, 2021
• Study Start: August 4, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)