Heart Failure With Reduced Ejection Fraction (HF-rEF)NCT07380555
The Effectiveness and Safety of Artificial Intelligence(AI)-Assisted Medical Treatment Decision Support System Compared to Conventional Care in HFrEF Patients
A study testing artificial intelligence (AI) decision support system in people with Heart Failure With Reduced Ejection Fraction (HF-rEF), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HF-rEF)
- What is being tested?
- artificial intelligence (AI) decision support system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are unable or unsuitable for follow-up.
- Patients with poor compliance, presenting a risk of switching study groups.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Shuai Yuan, shuaiyuanys94@163.com
Jingmin Zhou, MD
About this study
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
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:
Read more
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.
- Being tested
- artificial intelligence (AI) decision support system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| AI-Guided Group | Experimental | patients in this group will receive medication recommendations from an AI system based on patient health data. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (9)
All-cause rehospitalization
Hospitalization for any cause
Measured: From enrollment to 12 months follow-up
Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD)
The absolute change in the internal diameter of the left ventricle at the end of its filling phase (millimeters, mm).
Measured: Baseline and 12 months
Cardiovascular mortality
Death due to cardiovascular causes
Measured: From enrollment to 12 months follow-up
All-cause mortality
Death from any cause
Measured: From enrollment to 12 months follow-up
From enrollment to 12 months follow-up
The total count of heart failure-related hospitalizations per participant.
Measured: From enrollment to 12 months follow-up
Change from baseline in NT-proBNP level
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.
Measured: Baseline and 12 months
Change from baseline in Left Ventricular Ejection Fraction (LVEF)
The absolute change in the percentage of blood pumped out of the left ventricle with each contraction.
Measured: Baseline and 12 months
Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD)
The absolute change in the internal diameter of the left ventricle at the end of its filling phase(millimeters, mm).
Measured: Baseline and 12 months
Change from baseline in quality of life score as assessed by the EQ-5D
The change in the score from the EQ-5D quality of life questionnaire
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start30 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection Fraction (HF-rEF)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380555
- Sponsor's protocol ID
- B2025-392R2
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07380555
- Acronym / sponsor ID
- B2025-392R2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Guided Group | Experimental | Device: artificial intelligence (AI) decision support systempatients in this group will receive medication recommendations from an AI system based on patient health data. |
| Standard Care Group | No intervention | –patients in this group will receive medications as normally plan, without AI assistance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who are unable or unsuitable for follow-up.
- Patients with poor compliance, presenting a risk of switching study groups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| artificial intelligence (AI) decision support systemAccording 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 | Device | AI-Guided Group |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing artificial intelligence (AI) decision support system in people with Heart Failure With Reduced Ejection Fraction (HF-rEF), run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuai Yuan, MD (+8618516568776, shuaiyuanys94@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the composite endpoint of heart failure rehospitalization or cardiovascular death (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.