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

Official title

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

Overview

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.

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 subgrou

Primary outcome measures

• Composite outcome of death or HF hospitalization [Time frame: 2 years after randomization]

Secondary outcome measures (9)

• Change in GDMT score [Time frame: 90 days after randomization]
• NT-proBNP measures [Time frame: 2 years after randomization]
• Cardiovascular death [Time frame: 2 years after randomization]
• Stroke [Time frame: 2 years after randomization]
• Time to first readmission for heart failure (HF) [Time frame: 2 years after randomization]
• AF burden monitored by ECG straps [Time frame: 2 years after randomization]
• Changes in quality of life (QoL) using Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) [Time frame: 2 years after randomization]
• Changes in Quality of life (QoL) using Minnesota Heart Failure Quality of Life Scale (MLHFO) [Time frame: 2 years after randomization]
• Changes in quality of life (QoL) using a five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) [Time frame: 2 years 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 3. 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 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.

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: NCT07687862 · KS2026104

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗