Wearable Device-Assisted Remote Management in Atrial Fibrillation Complicated by Heart Failure: WARM-HF Trial

NCT07411170 | Not Yet Recruiting DMC

• 1 other identifier: KS2025250
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with acute decompensated heart failure (HF) have a significantly high risk of death and HF re-hospitalization during the vulnerable phase post discharge. Therefore, early post-discharge management is crucial, and the cornerstone of HF treatment-particularly for HF with reduced ejection fraction (HFrEF)-is guideline-directed medical therapy (GDMT), a comprehensive pharmacotherapeutic strategy supported by robust clinical evidence. Timely titration of GDMT, especially within the first few weeks after discharge, has been shown to improve clinical outcomes, reduce readmissions, and enhance long-term prognosis. However, ensuring optimal follow-up and therapeutic adjustments remains a major challenge in real-world practice. Atrial fibrillation (AF) is a common comorbidity in patients with HF, especially in those with severe HF. The presence of AF significantly complicates the clinical course and worsens the prognosis of HF. Advances in wearable technology have made continuous, non-invasive monitoring of vital signs, arrhythmia burden, and physical status increasingly feasible. Devices such as smartwatches and ECG belts can provide real-time physiological data, offering new opportunities for remote and proactive disease management. Despite the growing availability of such data, the complex interplay between AF and HF demands highly personalized management. Currently, there is a lack of high-quality clinical evidence on how to effectively integrate wearable device data into personalized strategies for this specific patient population. This is an open-label, multi-center, endpoint-blinded, parallel-group randomized clinical trial supported by the American Heart Association. The primary objective is to determine whether wearable device-assisted digital consultations can optimize GDMT in patients with AF complicated by acute decompensated HF. The study plans to enroll 400 participants, who will be randomly assigned to either a wearable device-assisted intervention group or a conventional treatment control group. The primary endpoint is the change in HF GDMT score 3 months after randomization. Apple Inc. provided funding, devices, and technical support for this study. Apple was not a sponsor of the trial and was not involved in its execution, data analysis, interpretation, or manuscript preparation.

Conditions

AF - Atrial Fibrillation; HFrEF - Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Changes in Heart Failure Guideline-directed Medical Therapy (GDMT) Score

  High score favorable

  3 Months After Randomization

Secondary Outcomes (3)

• AF recurrence monitored by Apple Watch and ECG belt

  3 Months After Randomization

• AF burden monitored by ECG belt

  12 Months After Randomization

• Time to first HF hospitalization and/or cardiovascular death

  12 Months After Randomization

Other Outcomes (10)

• Change in NT-proBNP level

  3 Months After Randomization

• Change in 6-minute walk test (6MWT) result

  3 Months After Randomization

• Change in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS)

  3 Months After Randomization

Study Arms (2)

Wearable Device-Assisted Intervention Group

EXPERIMENTAL

Other: Wearable Device-Assisted Intervention

Conventional Treatment Control Group

NO INTERVENTION

Interventions

Wearable Device-Assisted Intervention OTHER

This intervention comprises two core components: (A) A data collecting system via smartwatch and ECG belt; and (B) A decision-support algorithms for risk stratification and medication dose adjustment based on real-time data. Participants will be instructed to wear both the Apple Watch and ECG belt for a minimum of 12-18 hours per day to monitor parameters, such as heart rhythm and respiratory rate. Participants will be prompted via the research APP to complete questionnaires for symptom, blood pressure, and body weight data. All collected data are automatically uploaded to a secure cloud-based platform. A centralized decision-support system analyzes the integrated information using a suite of predefined, multi-layered algorithms to identify patients requiring intervention. Patients will be stratified into three tiers based on integrated physiological metrics and symptom reports: Normal subgroup, Abnormal subgroup, and E-alarm subgroup.

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) :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
• 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, uncorrected thyroid disease
• ST-segment elevation myocardial infarction (STEMI) within 3 months
• Known complex congenital/secondary heart disease; infiltrative cardiomyopathy (e.g., cardiac amyloidosis, sarcoidosis, lymphoma, or endomyocardial fibrosis); myocarditis; constrictive pericarditis; cardiac tamponade; hypertrophic cardiomyopathy; stress cardiomyopathy (Takotsubo cardiomyopathy); or uncorrected primary valvular heart disease requiring surgical intervention.
• Previous or planned major cardiac surgery or mechanical circulatory support 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.
• Current use of or planned implantation of a pacemaker.
• Contraindications to wearing a smartwatch (e.g., limb disability or known allergy to rubber/metal materials)
• Inability to access the Internet or lack of proficiency in operating smart devices
• Pregnant or lactating women
• Organ transplantation within the past 12 months
• Expected survival time of less than 1 year for any reason
• Refusal to participate or inability to comply with follow-up requirements
• Deemed ineligible for participation in the study by the investigators

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhiyao Wei, MD., PhD.

CONTACT

010-15521192379; weizhiyaoyx@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: January 26, 2026
• First Posted: February 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share