Smartwatch study aims to keep heart failure patients out of hospital
NCT ID NCT07411170
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This study tests whether using a wearable device (like a smartwatch) to monitor patients remotely can help doctors adjust heart failure medications more effectively. It includes 400 adults with both heart failure and atrial fibrillation. The goal is to improve treatment and reduce hospital readmissions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: 1. Age ≥ 18 years 2. Subjects diagnosed with acute decompensated heart failure (ADHF) :1)Heart failure with reduced ejection fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) ≤ 40%;2)New York Heart Association (NYHA) functional class II-IV;3)NT-proBNP \> 2500 pg/mL or BNP \> 600 pg/mL 3. Atrial fibrillation (AF) diagnosed during hospitalization (documented AF episode lasting \> 30 seconds on electrocardiogram \[ECG\] within the past 12 months) Exclusion Criteria: 1. Intolerance to heart failure pharmacotherapy 2. Severe anemia, uncorrected thyroid disease 3. ST-segment elevation myocardial infarction (STEMI) within 3 months 4. Known complex congenital/secondary heart disease; infiltrative cardiomyopathy (e.g., cardiac amyloidosis, sarcoidosis, lymphoma, or endomyocardial fibrosis); myocarditis; constrictive pericarditis; cardiac tamponade; hypertrophic cardiomyopathy; stress cardiomyopathy (Takotsubo cardiomyopathy); or uncorrected primary valvular heart disease requiring surgical intervention. 5. Previous or planned major cardiac surgery or mechanical circulatory support within 6 months, including coronary artery bypass grafting, cardiac valve repair or replacement, ventricular assist device or mechanical circulatory support device implantation, and heart transplantation. 6. Current use of or planned implantation of a pacemaker. 7. Contraindications to wearing a smartwatch (e.g., limb disability or known allergy to rubber/metal materials) 8. Inability to access the Internet or lack of proficiency in operating smart devices 9. Pregnant or lactating women 10. Organ transplantation within the past 12 months 11. Expected survival time of less than 1 year for any reason 12. Refusal to participate or inability to comply with follow-up requirements 13. Deemed ineligible for participation in the study by the investigators
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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