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Not yet recruiting NCT07380555

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

No phase Interventional Heart Failure With Reduced Ejection Fraction (HF-rEF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: artificial intelligence (AI) decision support system.
Who it may be relevant to
Registry conditions: Heart Failure With Reduced Ejection Fraction (HF-rEF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Incidence of the composite endpoint of heart failure rehospitalization or cardiovascular death [Time frame: 12 months]
Secondary outcome measures (9)
  • All-cause rehospitalization [Time frame: From enrollment to 12 months follow-up]
  • Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD) [Time frame: Baseline and 12 months]
  • Cardiovascular mortality [Time frame: From enrollment to 12 months follow-up]
  • All-cause mortality [Time frame: From enrollment to 12 months follow-up]
  • From enrollment to 12 months follow-up [Time frame: From enrollment to 12 months follow-up]
  • Change from baseline in NT-proBNP level [Time frame: Baseline and 12 months]
  • Change from baseline in Left Ventricular Ejection Fraction (LVEF) [Time frame: Baseline and 12 months]
  • Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD) [Time frame: Baseline and 12 months]
  • Change from baseline in quality of life score as assessed by the EQ-5D [Time frame: Baseline and 12 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT07380555 · B2025-392R2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗