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

NCT07355023 | Recruiting

• 1 other identifier: A202505041
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Left Ventricular (LV) Systolic Dysfunction

Keywords

Artificial intelligence; Electrocardiogram; Deep learning; Left ventricular dysfunction

Outcome Measures

Primary Outcomes (1)

• Rate of left ventricular ejection fraction (LVEF) ≤40%

  Rate of left ventricular ejection fraction (LVEF) ≤40% on follow-up echocardiography

  within follow-up period (up to 10 years)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

No Guideline-directed medical therapies

Interventions

Guideline-directed medical therapies BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taipei, 11490, Taiwan

RECRUITING

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Wei-Ting Liu, M.D.

CONTACT

+886287923311; wtliucv@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Doctor, Principal Investigator

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 21, 2026
• Study Start: January 1, 2026
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)