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Can your smartwatch spot heart failure clues?

NCT ID NCT04998877

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study looks at how data from wearable devices (like activity trackers and heart monitors) relates to heart and muscle function in people with a type of heart failure called HFpEF. Researchers will compare 60 adults with and without HFpEF using tests like MRI, exercise testing, and blood work. No treatment is given—the goal is to learn how wearables might help monitor the condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors use wearable devices to better monitor and manage heart failure with preserved ejection fraction (HFpEF).
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve health, and results may not apply to all patients with HFpEF.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

40 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * 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. 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 * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Johns Hopkins Hosptial

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.