Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07687862

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure and Reduced Ejection Fraction Heart Failure, Systolic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Composite outcome of death or HF hospitalization

    Time frame: 2 years after randomization

Secondary outcomes

  1. Change in GDMT score

    Time frame: 90 days after randomization

    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.

  2. NT-proBNP measures

    Time frame: 2 years after randomization

  3. Cardiovascular death

    Time frame: 2 years after randomization

  4. Stroke

    Time frame: 2 years after randomization

  5. Time to first readmission for heart failure (HF)

    Time frame: 2 years after randomization

  6. AF burden monitored by ECG straps

    Time frame: 2 years after randomization

  7. Changes in quality of life (QoL) using Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS)

    Time frame: 2 years after randomization

    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.

  8. Changes in Quality of life (QoL) using Minnesota Heart Failure Quality of Life Scale (MLHFO)

    Time frame: 2 years after randomization

    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.

  9. Changes in quality of life (QoL) using a five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)

    Time frame: 2 years after randomization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yihong Sun

CONTACT

[email protected]

+86 15001251357

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 7, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.