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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-Guided Group | Experimental | patients in this group will receive medication recommendations from an AI system based on patient health data. |
|
| Standard Care Group | No Intervention | patients in this group will receive medications as normally plan, without AI assistance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| artificial intelligence (AI) decision support system | Device | According to the data uploaded by patients, drug treatment plan were generated based on a prespecified AI-assisted decision-making system, which were reviewed by researchers and sent to patients |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the composite endpoint of heart failure rehospitalization or cardiovascular death | The occurrence of the first event of either hospitalization due to worsening heart failure or death from a cardiovascular cause. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause rehospitalization | Hospitalization for any cause | From enrollment to 12 months follow-up |
| Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD) | The absolute change in the internal diameter of the left ventricle at the end of its filling phase (millimeters, mm). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuai Yuan, MD | Contact | +8618516568776 | shuaiyuanys94@163.com | |
| Jingmin Zhou, MD | Contact | +8613601954136 | zhou.jingmin@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
The individual participant data collected in this study are not currently planned for sharing due to privacy and ethical constraints. However, reasonable requests for de-identified data will be considered by the corresponding investigator upon submission of a methodologically sound proposal.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2025 |
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| Baseline and 12 months |
| Cardiovascular mortality | Death due to cardiovascular causes | From enrollment to 12 months follow-up |
| All-cause mortality | Death from any cause | From enrollment to 12 months follow-up |
| From enrollment to 12 months follow-up | The total count of heart failure-related hospitalizations per participant. | From enrollment to 12 months follow-up |
| Change from baseline in NT-proBNP level | The absolute or relative change in the N-terminal pro-brain natriuretic peptide level from the start of the study to the follow-up time point. | Baseline and 12 months |
| Change from baseline in Left Ventricular Ejection Fraction (LVEF) | The absolute change in the percentage of blood pumped out of the left ventricle with each contraction. | Baseline and 12 months |
| Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD) | The absolute change in the internal diameter of the left ventricle at the end of its filling phase(millimeters, mm). | Baseline and 12 months |
| Change from baseline in quality of life score as assessed by the EQ-5D | The change in the score from the EQ-5D quality of life questionnaire | Baseline and 12 months |
| Jan 24, 2026 |
| Prot_SAP_000.pdf |