Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Not Yet Recruiting
NCT Number: NCT07380555
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
artificial intelligence (AI) decision support system
DeviceAccording 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 outcomes
-
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.
Secondary outcomes
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All-cause rehospitalization
Time frame: From enrollment to 12 months follow-up
Hospitalization for any cause
-
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).
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Cardiovascular mortality
Time frame: From enrollment to 12 months follow-up
Death due to cardiovascular causes
-
All-cause mortality
Time frame: From enrollment to 12 months follow-up
Death from any cause
-
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.
-
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.
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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.
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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).
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Jingmin Zhou, MD
CONTACT
Shuai Yuan, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Shanghai Zhongshan Hospital
Other
Registry information
Official study 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
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Feb 2, 2026
- Registry last updated
- Feb 2, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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