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The Effectiveness and Safety of Artificial Intelligence(AI)-Assisted Medical Treatment Decision Support System Compared to Conventional Care in HFrEF Patients
Sponsor: Shanghai Zhongshan Hospital
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2026-01-30
Completion Date
2027-12-31
Last Updated
2026-02-02
Healthy Volunteers
No
Interventions
artificial intelligence (AI) decision support system
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
Locations (1)
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China