NCT07380555

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

January 12, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

January 12, 2026

Last Update Submit

January 24, 2026

Conditions

Heart Failure With Reduced Ejection Fraction (HF-rEF)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • All-cause rehospitalization

    From enrollment to 12 months follow-up

  • Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD)

    Baseline and 12 months

  • Cardiovascular mortality

    From enrollment to 12 months follow-up

  • All-cause mortality

    From enrollment to 12 months follow-up

  • From enrollment to 12 months follow-up

    From enrollment to 12 months follow-up

  • +4 more secondary outcomes

Study Arms (2)

AI-Guided Group

EXPERIMENTAL

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

Device: artificial intelligence (AI) decision support system

Standard Care Group

NO INTERVENTION

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

Interventions

artificial intelligence (AI) decision support systemDEVICE

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

AI-Guided Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Central Study Contacts

Shuai Yuan, MD

CONTACT

+8618516568776shuaiyuanys94@163.com

Jingmin Zhou, MD

CONTACT

+8613601954136zhou.jingmin@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

February 2, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations

CN(1)