CompletedNot Applicable

AI-ECG for Time-Resolved Prediction of HFrEF

China286,709 participantsStarted 2014-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Adults aged ≥18 years Underwent standard 12-lead electrocardiography (ECG) Underwent transthoracic echocardiography with available LVEF measurement Availability of paired ECG-echocardiography data Data available for follow-up assessment Exclusion Criteria: Missing or incomplete ECG or echocardiography data Poor-quality ECG recordings unsuitable for analysis Missing key clinical variables required for model development

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incident Heart Failure With Reduced Ejection Fraction (HFrEF)

Timeframe: Up to 5 years

Trial details

NCT IDNCT07519434

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Heart Failure trials