[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646361":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":23,"locations":11,"responsibleParty":29,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":11,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":11,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":11},{"fullName":5,"class":6},"Beijing Anzhen Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Wearable Device-Assisted Intervention Group","EXPERIMENTAL",null,[13],"Drug: wearable device based remote management (GDMT titration for HF, rhythm control and anticoagulation management for AF)",{"label":15,"type":16,"description":11,"interventionNames":11},"Usual Care","NO_INTERVENTION",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"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\u002For 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\u002Fdownward GDMT titration, or volume\u002Fcongestion management (dyspnea\u002Fedema) - 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.",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Yihong Sun","CONTACT","+86 15001251357","yihongsun72@163.com",{"type":30,"investigatorFullName":25,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Chief Physician","100646361","wearable-device-assisted-remote-management-to-improve-prognosis-in-patients-with-acute-heart-failure-complicated-by-atrial-fibrillation-warm-hf-trial-stage-2-100646361",false,"NCT07687862","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","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Subjects diagnosed with acute decompensated heart failure (ADHF) :\n\n1)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\u002FmL or BNP \\> 600 pg\u002FmL 3. Atrial fibrillation (AF) diagnosed during hospitalization (documented AF episode lasting \\> 30 seconds on electrocardiogram \\[ECG\\] within the past 12 months)\n\nExclusion Criteria:\n\n1. Intolerance to heart failure pharmacotherapy;\n2. Severe anemia or untreated thyroid disease;\n3. ST-segment elevation myocardial infarction within 3 months;\n4. 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;\n5. 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;\n6. Existing pacemaker or planned pacemaker implantation;\n7. Contraindications to wearing a smartwatch (such as limb disability or known allergy to rubber\u002Fmetal materials);\n8. Inability to access the Internet or lack of proficiency in operating smart devices.","ALL","18 Years",{"count":42,"type":43},818,"ESTIMATED","INTERVENTIONAL",[46],"NA","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).\n\nIn 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.",[49,50],"Atrial Fibrillation (AF)","Heart Failure and Reduced Ejection Fraction","NOT_YET_RECRUITING","2026-07-07",{"date":54,"type":55},"2026-07-09","ACTUAL",{"date":57,"type":43},"2026-09-01",{"date":59,"type":43},"2028-12-30",{"name":5,"class":6}]