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

January 24, 2026 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Shanghai Zhongshan Hospital
        • Contact:
        • Principal Investigator:
          • Jingmin Zhou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-Guided Group
patients in this group will receive medication recommendations from an AI system based on patient health data.
Device: 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
No Intervention: Standard Care Group
patients in this group will receive medications as normally plan, without AI assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of the composite endpoint of heart failure rehospitalization or cardiovascular death
Time Frame: 12 months
The occurrence of the first event of either hospitalization due to worsening heart failure or death from a cardiovascular cause.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause rehospitalization
Time Frame: From enrollment to 12 months follow-up
Hospitalization for any cause
From enrollment to 12 months follow-up
Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD)
Time Frame: Baseline and 12 months
The absolute change in the internal diameter of the left ventricle at the end of its filling phase (millimeters, mm).
Baseline and 12 months
Cardiovascular mortality
Time Frame: From enrollment to 12 months follow-up
Death due to cardiovascular causes
From enrollment to 12 months follow-up
All-cause mortality
Time Frame: From enrollment to 12 months follow-up
Death from any cause
From enrollment to 12 months follow-up
From enrollment to 12 months follow-up
Time Frame: 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
Time Frame: Baseline and 12 months
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)
Time Frame: Baseline and 12 months
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)
Time Frame: Baseline and 12 months
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
Time Frame: Baseline and 12 months
The change in the score from the EQ-5D quality of life questionnaire
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • B2025-392R2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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