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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 818
- 主要终点
- Composite outcome of death or HF hospitalization
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Subjects diagnosed with acute decompensated heart failure (ADHF) :
- •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)
排除标准
- •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.
研究组 & 干预措施
Wearable Device-Assisted Intervention Group
干预措施: wearable device based remote management (GDMT titration for HF, rhythm control and anticoagulation management for AF) (Drug)
Usual Care
结局指标
主要结局
Composite outcome of death or HF hospitalization
时间窗: 2 years after randomization
次要结局
- Change in GDMT score(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)(2 years after randomization)
- Changes in Quality of life (QoL) using Minnesota Heart Failure Quality of Life Scale (MLHFO)(2 years after randomization)
- Changes in quality of life (QoL) using a five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)(2 years after randomization)
研究者
Yihong Sun
Chief Physician
Beijing Anzhen Hospital