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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTri-Service General Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

With an ECG followed by an echocardiogram within a 90-day interval

With preserved left ventricular ejection fraction (LVEF ≥ 50%)

Disqualifiers

missing essential variables or ECG lead data

any prior LVEF < 50%

loss to follow-up or death during the 90-day assessment window

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

5,000 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
within follow-up period (up to 10 years)

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Tri-Service General HospitalRecruiting11490, Taipei, TaipeiTaiwanTaiwan

Sponsors and contacts

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