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NCT07519434

AI-ECG for Time-Resolved Prediction of HFrEF

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

This study aims to develop and validate a deep learning-based electrocardiogram (ECG) model for predicting the future risk of heart failure with reduced ejection fraction (HFrEF). The model is trained using raw 12-lead ECG data and generates individualized, time-resolved risk estimates over a 5-year period. Data are obtained from multiple cohorts, including Zhongshan Hospital, Shanghai Tenth People's Hospital, and Beth Israel Deaconess Medical Center, representing diverse populations across China and the United States. The model is designed to identify individuals at elevated risk of developing HFrEF before the onset of overt clinical disease. The performance of the model is evaluated using multiple complementary metrics, including discrimination, calibration, and clinical utility. In addition, interpretability analyses are conducted to explore the physiological relevance of ECG features associated with predicted risk. This study seeks to provide an accessible and scalable tool for early risk stratification of heart failure, with the potential to support timely clinical decision-making and improve patient outcomes.

Official title: Electrocardiogram-Based Deep Learning for Time-Resolved Prediction of Heart Failure With Reduced Ejection Fraction: A Multinational Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

286709

Start Date

2014-02

Completion Date

2023-12

Last Updated

2026-04-09

Healthy Volunteers

Yes

Locations (1)

Shanghai, Shanghai Municipality, China