NCT07519434Completed
AI-ECG for Time-Resolved Prediction of HFrEF
Electrocardiogram-Based Deep Learning for Time-Resolved Prediction of Heart Failure With Reduced Ejection Fraction: A Multinational Study
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 286709 (actual)
- First submitted
- 2 Apr 2026
- Start date
- Feb 2014
- Primary completion date
- Dec 2023
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Heart failure
- NCT number
- NCT07519434
What you commit to
- Study type: Observational
- Participants enrolled: 286709
- From Feb 2014 to the primary completion date, Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Missing or incomplete ECG or echocardiography data Poor-quality ECG recordings unsuitable for analysis Missing key clinical variables required for model development
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.