NCT07380555Not yet recruiting
The Effectiveness and Safety of Artificial Intelligence(AI)-Assisted Medical Treatment Decision Support System Compared to Conventional Care in HFrEF Patients
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
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1200 (estimated)
- First submitted
- 12 Jan 2026
- Start date
- 30 Jan 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Heart failure
- NCT number
- NCT07380555
What you commit to
- Study type: Interventional
- Planned participants: 1200
- From 30 Jan 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients who are unable or unsuitable for follow-up.
- Patients with poor compliance, presenting a risk of switching study groups.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.