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

A Researcher-initiated, Prospective, Open-label, Randomized Controlled Trial With a Parallel Design to Investigate the Prognostic Impact of Wearable Device-assisted Remote Management in Patients With Acute Heart Failure Complicated by Atrial Fibrillation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation (AF); Heart Failure and Reduced Ejection Fraction
• Intervention / Treatment: Drug: wearable device based remote management (GDMT titration for HF, rhythm control and anticoagulation management for AF)

• Study Type: Interventional
• Enrollment (Estimated): 818
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yihong Sun; Phone Number: +86 15001251357; Email: yihongsun72@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years;
2. 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 3. Atrial fibrillation (AF) diagnosed during hospitalization (documented AF episode lasting > 30 seconds on electrocardiogram [ECG] within the past 12 months)

Exclusion Criteria:

1. Intolerance to heart failure pharmacotherapy;
2. Severe anemia or untreated thyroid disease;
3. ST-segment elevation myocardial infarction within 3 months;
4. 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;
5. 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;
6. Existing pacemaker or planned pacemaker implantation;
7. Contraindications to wearing a smartwatch (such as limb disability or known allergy to rubber/metal materials);
8. Inability to access the Internet or lack of proficiency in operating smart devices.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Wearable Device-Assisted Intervention Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite outcome of death or HF hospitalization	2 years after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in GDMT score	The GDMT(guideline-directed medical therapy) score is a scoring system according to the combination of GDMT drugs administration and their dosages. Renin-angiotensin system (RAS) inhibitors were scored 0 if not initiated, 1 if <50% of target dose, and 2 if 50-100% of target dose; ARNIs were scored 3 regardless of dose; BBs were scored 0 if not initiated, 1 if <50% of target dose, and 2 if 50-100% of target dose; and MRAs and SGLT2 inhibitors were scored 0 if not initiated and 2 if initiated regardless of dose. MRAs and SGLT2 inhibitors were scored 0 if not initiated and 2 if initiated regardless of dose, resulting in a total score of 0-9. The higher score indicated better implementation of GDMT therapy.	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
AF burden monitored by ECG straps		2 years after randomization
Changes in quality of life (QoL) using Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS)	The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life for patients with congestive heart failure. The KCCQ-OS scores range from 0 to 100, with lower scores denoting poorer quality of life.	2 years after randomization
Changes in Quality of life (QoL) using Minnesota Heart Failure Quality of Life Scale (MLHFO)	The Minnesota Failure Quality of Life Scale (MLHFO) was especially developed for patients with HF to measure their overall health-related quality of life. It contains 21 questions about the impact of HF on patient's daily life. A total score between 0 and 105 can be achieved, with a higher score indicating poorer quality of life.	2 years after randomization
Changes in quality of life (QoL) using a five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)	The descriptive system of the EuroQol five-dimensional questionnaire(EQ-5D) comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension is described at five levels, corresponding roughly to no, slight, moderate, severe, and extreme problems. A health profile and a single health state index value can be derived. This index value ranges between <0 (where 0 is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). In addition, a visual analogue scale records the respondent's self-rated health status on a vertical graduated (0-100) scale.	2 years after randomization

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Failure; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Heart Failure, Systolic
• Other Study ID Numbers: KS2026104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No