Actively Recruiting
AI-Enabled Electrocardiogram-Guided Medical Therapy to Prevent Left Ventricular Dysfunction: A Retrospective Target Trial Emulation Study
Led by Tri-Service General Hospital · Updated on 2026-01-21
5000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether artificial intelligence-enabled electrocardiography (AI-ECG) can identify people at high risk for left ventricular dysfunction and if early use of guideline-directed medical therapies can reduce this risk. This multicenter retrospective study uses data from Taiwan's healthcare system collected between 2016 and 2024, focusing on patients with preserved left ventricular systolic function at baseline. The study applies AI-ECG risk stratification and emulates a target trial to assess therapy impacts on heart function decline. The study compares patients starting guideline-directed medical therapies—such as angiotensin converting enzyme inhibitors (ACEi), angiotensin II receptor blockers (ARB), beta-blockers, and sodium-glucose cotransporter 2 (SGLT2) inhibitors—against those not receiving these treatments. AI-ECG models developed from over 50,000 paired ECG and echocardiogram recordings identify high-risk individuals despite normal initial ejection fraction. The study evaluates the association between early preventive medication use and incident left ventricular dysfunction. Participants must have had both an ECG and echocardiogram within 90 days and preserved heart pumping function initially. Researchers will review medical records, medication prescriptions, ECGs, and echocardiography results. The main measurement is the rate of left ventricular ejection fraction dropping to 40% or below during up to 10 years of follow-up. Safety and outcomes will be monitored using real-world data, with analyses exploring robustness across clinical settings and patient profiles.
CONDITIONS
Brief Title
AI-Enabled Electrocardiogram-Guided Guideline-Directed Medical Therapy on Incident Left Ventricular Dysfunction: A Target Trial Emulation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Had an ECG followed by an echocardiogram within a 90-day interval
- Preserved left ventricular ejection fraction (LVEF 50% or higher) at baseline
You will not qualify if you...
- Missing essential variables or ECG lead data
- Any prior left ventricular ejection fraction (LVEF) below 50%
- Loss to follow-up or death during the 90-day assessment window
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants receive guideline-directed medical therapies for patients at risk of heart failure, including angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), beta-blockers, and sodium-glucose cotransporter 2 (SGLT2) inhibitors if they are in the intervention group, or no intervention if in the control group.
Follow-up visits as part of routine care
Trial Site Locations
Total: 1 location
1
Tri-Service General Hospital
Taipei, Taipei, Taiwan, 11490
Actively Recruiting
Research Team
W
Wei-Ting Liu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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