Heart Failure With Reduced Ejection Fraction (HF-rEF)
Conditions
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.
Interventions
DEVICEartificial 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
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old; 2. Patients diagnosed with HF in hospital and discharged on medical orders; 3. LVEF≤40% detected by echocardiography within 1 month before enrollment; 4. Signed informed consent is obtained.
Exclusion criteria
1. Patients who are unable or unsuitable for follow-up. 2. Patients with poor compliance, presenting a risk of switching study groups.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of the composite endpoint of heart failure rehospitalization or cardiovascular death | 12 months | The occurrence of the first event of either hospitalization due to worsening heart failure or death from a cardiovascular cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause rehospitalization | From enrollment to 12 months follow-up | Hospitalization for any cause |
| Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD) | Baseline and 12 months | The absolute change in the internal diameter of the left ventricle at the end of its filling phase (millimeters, mm). |
| Cardiovascular mortality | From enrollment to 12 months follow-up | Death due to cardiovascular causes |
| All-cause mortality | From enrollment to 12 months follow-up | Death from any cause |
| From enrollment to 12 months follow-up | From enrollment to 12 months follow-up | The total count of heart failure-related hospitalizations per participant. |
| Change from baseline in NT-proBNP level | 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. |
| Change from baseline in Left Ventricular Ejection Fraction (LVEF) | Baseline and 12 months | The absolute change in the percentage of blood pumped out of the left ventricle with each contraction. |
| Change from baseline in quality of life score as assessed by the EQ-5D | Baseline and 12 months | The change in the score from the EQ-5D quality of life questionnaire |
Countries
China
Contacts
CONTACTShuai Yuan, MD
CONTACTJingmin Zhou, MD
Outcome results
None listed