The Effectiveness and Safety of Artificial Intelligence(AI)-Assisted Medical Treatment Decision Support System Compared to Conventional Care in HFrEF Patients

Официальное название

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

Обзор

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.

Вмешательства

• Устройство artificial 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

Первичные конечные точки

• Incidence of the composite endpoint of heart failure rehospitalization or cardiovascular death [Срок оценки: 12 months]

Вторичные конечные точки (9)

• All-cause rehospitalization [Срок оценки: From enrollment to 12 months follow-up]
• Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD) [Срок оценки: Baseline and 12 months]
• Cardiovascular mortality [Срок оценки: From enrollment to 12 months follow-up]
• All-cause mortality [Срок оценки: From enrollment to 12 months follow-up]
• From enrollment to 12 months follow-up [Срок оценки: From enrollment to 12 months follow-up]
• Change from baseline in NT-proBNP level [Срок оценки: Baseline and 12 months]
• Change from baseline in Left Ventricular Ejection Fraction (LVEF) [Срок оценки: Baseline and 12 months]
• Change from baseline in Left Ventricular End-Diastolic Diameter (LVEDD) [Срок оценки: Baseline and 12 months]
• Change from baseline in quality of life score as assessed by the EQ-5D [Срок оценки: Baseline and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Zhongshan Hospital — Шанхай

Идентификаторы

NCT: NCT07380555 · B2025-392R2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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