AI-Enabled Electrocardiogram-Guided Guideline-Directed Medical Therapy on Incident Left Ventricular Dysfunction: A Target Trial Emulation Study

January 12, 2026 updated by: Wei-Ting Liu, Tri-Service General Hospital
This multicenter retrospective study evaluates whether artificial intelligence-enabled electrocardiography (AI-ECG) can identify individuals at high risk for left ventricular dysfunction and whether targeted guideline-directed medical therapy can mitigate subsequent risk. Using a large multicenter cohort of patients with preserved left ventricular systolic function, the investigators applied an AI-ECG-based risk stratification approach and emulated a target trial to examine the association between guideline-directed therapies and the risk of incident left ventricular functional decline.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This retrospective, multicenter study utilized electronic medical record (EMR) data from a nationwide healthcare system in Taiwan, comprising one academic medical center and seven regional hospitals. The study period extended from January 2016 through December 2024. Clinical data included demographics, comorbidities, medication prescriptions, 12-lead electrocardiograms, and transthoracic echocardiography results.

An artificial intelligence-enabled electrocardiography (AI-ECG) model was developed to detect left ventricular dysfunction (LVD) using over 50,000 paired ECG-echocardiogram recordings obtained within a 7-day interval. The model architecture consisted of an 82-layer convolutional neural network incorporating an attention mechanism to capture salient temporal and morphological ECG features. The finalized model was applied without modification to the study cohort for risk stratification.

All eligible patients had preserved left ventricular ejection fraction (LVEF) at baseline. Based on AI-ECG predictions at cohort entry, patients classified as having LVD by the model despite normal baseline LVEF were designated as the AI-ECG high-risk group, whereas those predicted not to have LVD were designated as the AI-ECG low-risk group. The primary outcome was incident left ventricular functional decline, defined as a reduction in LVEF to ≤40% on follow-up echocardiography.

Candidate preventive therapies, including angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB) , beta-blockers and sodium-glucose cotransporter 2 (SGLT2) inhibitors were first screened by evaluating their individual and combination prescription patterns and their associations with the primary outcome. The most promising therapy identified in this screening phase was subsequently assessed using a target trial emulation framework. Specifically, newly initiated use of the candidate therapy was compared with nonuse to emulate a randomized controlled trial, thereby estimating the effect of early preventive treatment on incident LVEF decline using real-world observational data.

The investigators prespecified analytic methods to estimate causal contrasts using time-to-event analyses suitable for observational data, following emulation of random treatment assignment. Prespecified sensitivity analyses were conducted to assess the robustness of the findings across different clinical settings, comorbidity profiles, concomitant therapies, and alternative AI-ECG risk thresholds.

Study Type

Interventional

Enrollment (Estimated)

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wei-Ting Liu, M.D.
  • Phone Number: 16118 +886287923311
  • Email: wtliucv@gmail.com

Study Locations

  • Taiwan
    • Taipei
      • Taipei, Taipei, Taiwan, 11490
        • Recruiting
        • Tri-Service General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • With an ECG followed by an echocardiogram within a 90-day interval
  • With preserved left ventricular ejection fraction (LVEF ≥ 50%)

Exclusion Criteria:

  • missing essential variables or ECG lead data
  • any prior LVEF < 50%
  • loss to follow-up or death during the 90-day assessment window

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Initiation of Guideline-directed medical therapies, including angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB) , beta-blockers and sodium-glucose cotransporter 2 (SGLT2) inhibitors
Behavioral: Guideline-directed medical therapies
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.
No Intervention: Control
No Guideline-directed medical therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of left ventricular ejection fraction (LVEF) ≤40%
Time Frame: within follow-up period (up to 10 years)
Rate of left ventricular ejection fraction (LVEF) ≤40% on follow-up echocardiography
within follow-up period (up to 10 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 15, 2026

Study Completion (Estimated)

January 15, 2026

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A202505041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Left Ventricular (LV) Systolic Dysfunction

Clinical Trials on Guideline-directed medical therapies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe