Wearable Device-Assisted Remote Management to Improve Prognosis in Patients With Acute Heart Failure Complicated by Atrial Fibrillation: WARM-HF Trial (Stage 2)

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.

NCT Number	NCT07687862
Lead Sponsor	Beijing Anzhen Hospital
Conditions	Atrial Fibrillation (AF), Heart Failure and Reduced Ejection Fraction
Enrollment	818 participants
Start Date	2026-09-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-09