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

Official title

Wearable Device-assisted Remote Management for Patients With Atrial Fibrillation Complicated by Heart Failure: A Prospective, Open-label, Multi-center, Randomized Controlled Trial

Overview

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.

Interventions

• Other Wearable Device-Assisted Intervention
  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

Primary outcome measures

• Changes in Heart Failure Guideline-directed Medical Therapy (GDMT) Score [Time frame: 3 Months After Randomization]

Secondary outcome measures (3)

• AF recurrence monitored by Apple Watch and ECG belt [Time frame: 3 Months After Randomization]
• AF burden monitored by ECG belt [Time frame: 12 Months After Randomization]
• Time to first HF hospitalization and/or cardiovascular death [Time frame: 12 Months After Randomization]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07411170 · KS2025250

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗