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

NCT07687862 | Not Yet Recruiting DMC

• 1 other identifier: KS2026104
• Study Type: interventional
• Target: 818
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Composite outcome of death or HF hospitalization

  2 years after randomization

Secondary Outcomes (9)

• Change in GDMT score

  90 days after randomization

• NT-proBNP measures

  2 years after randomization

• Cardiovascular death

  2 years after randomization

• Stroke

  2 years after randomization

• Time to first readmission for heart failure (HF)

  2 years after randomization

Study Arms (2)

Wearable Device-Assisted Intervention Group

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Wearable Device-Assisted Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Subjects diagnosed with acute decompensated heart failure (ADHF) :
• )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)

You may not qualify if:

• 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;
• 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;
• Existing pacemaker or planned pacemaker implantation;
• Contraindications to wearing a smartwatch (such as limb disability or known allergy to rubber/metal materials);
• Inability to access the Internet or lack of proficiency in operating smart devices.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Failure

Central Study Contacts

Yihong Sun

CONTACT

+86 15001251357; yihongsun72@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share