The Effectiveness and Safety of Artificial Intelligence(AI)-Assisted Medical Treatment Decision Support System Compared to Conventional Care in HFrEF Patients

Fudan University

Status: Not yet enrolling

Conditions: Heart Failure With Reduced Ejection Fraction (HF-rEF)

Treatments: Device: artificial intelligence (AI) decision support system

Study type: Interventional

Funder types: Other

Identifiers

NCT07380555

B2025-392R2

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old;
2. Patients diagnosed with HF in hospital and discharged on medical orders;
3. LVEF≤40% detected by echocardiography within 1 month before enrollment;
4. Signed informed consent is obtained.

Exclusion criteria

1. Patients who are unable or unsuitable for follow-up.
2. Patients with poor compliance, presenting a risk of switching study groups.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,200 participants in 2 patient groups

AI-Guided Group

Experimental group

Description:

patients in this group will receive medication recommendations from an AI system based on patient health data.

Treatment:

Device: artificial intelligence (AI) decision support system

Standard Care Group

No Intervention group

Description:

patients in this group will receive medications as normally plan, without AI assistance.