MedTrace Logo

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

NCT07687862 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 818

Last updated 2026-07-09

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

wearable device based remote management (GDMT titration for HF, rhythm control and anticoagulation management for AF)

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.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-12-31
Completion
2028-12-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07687862 on ClinicalTrials.gov