Heart Failure With Preserved Ejection FractionNCT04998877
Physical Activity, Cardiac and Skeletal Muscle Energetics in Healthy Subjects and HFpEF Patients
An observational study of Heart Failure With Preserved Ejection Fraction, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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 :
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- 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.
Who cannot join
- 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:
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- 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:
- Screening supine 12 lead ECG demonstrating evidence of prior infarction or ischemia, significant arrhythmia or clinically significant conduction abnormalities.
- Uncontrolled hypertension, or those participants requiring greater than 2 blood pressure lowering medications.
- Screening Fasting glucose level of ≥126 mg/dL.
- History of diabetes mellitus
- Significant heart or vascular disease, including a history of heart failure, myocardial infarction, revascularization or positive exercise tolerance test for ischemia (if previously performed).
- Other medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Heart Failure Participants Only:
- History of infiltrative cardiomyopathy or constrictive pericarditis, cor pulmonale, or significant pulmonary disease.
- Significant valvular abnormalities.
- History of clinical coronary artery disease (CAD) or significant epicardial coronary disease (>50% stenosis) in major coronary artery by x-ray or CT angiography unless (a) the patient underwent prior successful revascularization with percutaneous coronary angioplasty within the prior three years.
- Any condition other than HF which could limit the ability to perform a six minute walk test (6MWT) or CPET test (e.g., critical peripheral vascular disease, significant orthopedic or neurological conditions),
- Any diseases other than HF which are likely to significantly alter the patient's global perception of status or quality of life over a period of 6 months.
- Participants who have previously had a transplanted kidney, liver, or heart.
- At Screening, persistent severe, uncontrolled hypertension; for example: seated systolic blood pressure (SBP) ≥180 mm Hg and/or diastolic blood pressure (DBP) ≥105 mm Hg after ≥5 minute of seated rest, with a single repeat permitted to assess eligibility, if needed.
- At Screening, participants with an estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, and serum creatinine (SCr).
- Patients taking combined glucagon-like peptide and gastric inhibitory polypeptide (GLP-1/GIP) receptor agonists at the time of the screening study visit.
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure with Preserved Ejection Fraction | Not described | |
| Healthy Volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days
Secondary outcomes (2)
Difference of additional daily activity measures based on accelerometry between HFpEF participants and adults without HFpEF.
Sedentary Activity (minutes per day);
Measured: Up to 28 days
Rate of skeletal muscle phosphocreatine (PCr) decline during exercise normalized by work performed.
Difference between adults with and without HFpEF in rate of skeletal muscle [PCr] decline during exercise normalized by work performed.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start4 Aug 2021
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Robert G Weiss, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998877
- Sponsor's protocol ID
- IRB00270339
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Cardiac and Skeletal Muscle Energetics in Healthy Subjects and HFpEF Patients
- ClinicalTrials.gov ID
- NCT04998877
- Acronym / sponsor ID
- IRB00270339
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure with Preserved Ejection Fraction | – | – |
| Healthy Volunteers | – | – |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (20 listed)
- 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 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).
Key exclusion criteria (31 listed)
- All participants
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Difference of additional daily activity measures based on accelerometry between HFpEF participants and adults without HFpEF.
Time frame: Up to 28 days
Rate of skeletal muscle phosphocreatine (PCr) decline during exercise normalized by work performed.
Time frame: Up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert G Weiss, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of daily activity measures based on accelerometry between HFpEF participants and adults without HFpEF. (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.