NCT07687862Not yet recruiting
Wearable Device-Assisted Remote Management to Improve Prognosis in Patients With Acute Heart Failure Complicated by Atrial Fibrillation: WARM-HF Trial (Stage 2)
A Researcher-initiated, Prospective, Open-label, Randomized Controlled Trial With a Parallel Design to Investigate the Prognostic Impact of Wearable Device-assisted Remote Management in Patients With Acute Heart Failure Complicated by Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
With the advancement of wearable technology, continuous non-invasive monitoring of vital signs, arrhythmia burden, and physical status has become increasingly feasible. Devices such as smartwatches and electrocardiogram (ECG) straps can provide real-time physiological data, offering new opportunities for remote and proactive disease management. Despite the growing availability of such real-time data, the complex interaction between atrial fibrillation (AF) and heart failure (HF) necessitates highly personalized management. However, there remains a lack of high-quality clinical evidence on how to effectively integrate wearable device data into these personalized strategies for specific patient populations. Moreover, the prognostic impact of wearable device-assisted remote management has not been comprehensively evaluated. Therefore, robust clinical studies are needed to further evaluate whether wearable device-assisted remote monitoring can improve the long-term prognosis of this population after discharge from the cardiac care unit (CCU). In this study (WARM-HF Stage 2), the investigators will conduct a prospective, multicenter, randomized controlled trial to determine whether wearable devices can reduce the composite endpoint of readmission or death in patients with HF.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 818 (estimated)
- First submitted
- 25 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT07687862
What you commit to
- Study type: Interventional
- Planned participants: 818
- From 1 Sept 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior major cardiac surgery or mechanical circulatory support, or planned 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;
Other illness
- Intolerance to heart failure pharmacotherapy;
- Severe anemia or untreated thyroid disease;
- ST-segment elevation myocardial infarction within 3 months;
- Known complex congenital heart disease; infiltrative cardiomyopathy (such as cardiac amyloidosis, sarcoidosis, lymphoma, or endomyocardial fibrosis); myocarditis; constrictive pericarditis; cardiac tamponade; hypertrophic cardiomyopathy; stress cardiomyopathy; or uncorrected primary valvular heart disease requiring surgical interventions;
- Contraindications to wearing a smartwatch (such as limb disability or known allergy to rubber/metal materials);
Other
- Existing pacemaker or planned pacemaker implantation;
- Inability to access the Internet or lack of proficiency in operating smart devices.
Who the study is looking for
- Age ≥ 18 years;
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.