A Multicenter, Cluster-randomized, Controlled Study Evaluating the Effectiveness and Safety of Artificial Intelligence(AI)-Assisted Medical Treatment Decision Support System Compared to Conventional Care in HFrEF Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Incidence of the composite endpoint of heart failure rehospitalization or cardiovascular death
研究概览
简要总结
This clinical trial aims to find out if using an artificial intelligence (AI) decision support system can help doctors better manage medications for people with heart failure with reduced ejection fraction (HFrEF). The main goal is to see if this approach can lower the chance of patients being hospitalized for heart failure or dying from heart-related causes compared to standard care.
About 1,200 participants from 60 hospitals will take part in this study. The hospitals, not the individual patients, are randomly assigned to one of two groups:
AI-Guided Group: Doctors at these hospitals will receive medication recommendations from an AI system based on patient health data.
Standard Care Group: Doctors at these hospitals will manage medications as they normally would, without AI assistance.
All participants will have regular check-ups, both remotely every 30 days and in-person at 3, 6, and 12 months. The study will last about 12 months for each participant.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 old;
- •Patients diagnosed with HF in hospital and discharged on medical orders;
- •LVEF≤40% detected by echocardiography within 1 month before enrollment;
- •Signed informed consent is obtained.
排除标准
- •Patients who are unable or unsuitable for follow-up.
- •Patients with poor compliance, presenting a risk of switching study groups.
研究组 & 干预措施
AI-Guided Group
patients in this group will receive medication recommendations from an AI system based on patient health data.
干预措施: artificial intelligence (AI) decision support system (Device)
Standard Care Group
patients in this group will receive medications as normally plan, without AI assistance.
结局指标
主要结局
Incidence of the composite endpoint of heart failure rehospitalization or cardiovascular death
时间窗: 12 months
The occurrence of the first event of either hospitalization due to worsening heart failure or death from a cardiovascular cause.
次要结局
- All-cause rehospitalization(From enrollment to 12 months follow-up)
- Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD)(Baseline and 12 months)
- Cardiovascular mortality(From enrollment to 12 months follow-up)
- All-cause mortality(From enrollment to 12 months follow-up)
- From enrollment to 12 months follow-up(From enrollment to 12 months follow-up)
- Change from baseline in NT-proBNP level(Baseline and 12 months)
- Change from baseline in Left Ventricular Ejection Fraction (LVEF)(Baseline and 12 months)
- Change from baseline in quality of life score as assessed by the EQ-5D(Baseline and 12 months)