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

Sponsor
Beijing Anzhen Hospital
Study ID
NCT07687862
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation (AF)
  • Heart Failure and Reduced Ejection Fraction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • wearable device based remote management (GDMT titration for HF, rhythm control and anticoagulation management for AF) — DRUG
    Participants in the intervention group will be managed per current guidelines for heart failure (HF) and/or atrial fibrillation (AF). The intervention group uses real-time data for automatic triage, categorized into three subgroups: Normal subgroup: Upward titration of guideline-directed medical therapy (GDMT). Abnormal subgroup: Upward/downward GDMT titration, or volume/congestion management (dyspnea/edema) - diuretics titrated to 100% target dose or other diuretics added. Grade E alert subgroup: Emergency department (ED) or outpatient clinic visit. Efforts to maintain sinus rhythm are recommended; rate control strategies are at the discretion of physicians. Anticoagulation will be initiated, if not already started, and maintained throughout the study according to current guidelines.

Study Details

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.

Key Dates

First listed
Jul 7, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
818 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Wearable Device-Assisted Intervention Group
  • No Intervention: Usual Care

Primary Outcome Measure

Composite outcome of death or HF hospitalization [ Time Frame: 2 years after randomization ]

Central Contacts

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