Clinical Trial

Artificial Intelligence Versus Sonographer Echocardiogram Analysis and Reporting in Patients With Heart Failure

Study acronym: AISEARHF
Not Yet Recruiting
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Summary
This is a non-inferiority, three-year, multicenter, double-blinded randomized controlled study of an AI versus experienced sonographer echocardiogram analysis in HF patients. Consecutive patients presented for echocardiogram examination with new or worsening HF symptom and positive HF blood markers will be recruited. A target of 514 patients will be randomized 1:1 to receive either AI or sonographer echocardiogram analysis. The primary endpoint of diagnostic accuracy is the complete agreement of disease grading with an experienced cardiologist (American Society of Echocardiography level III) using a standardized grading chart. Important secondary endpoints include the time used for echocardiogram report drafting and report endorsement, 6-month heart failure symptom and hospitalization, and the cost-effectiveness of AI to increase echocardiogram service. Clinical, biochemical and echocardiographic predictors of worsening of heart failure and hospitalization will be identified.
Trial Details
NCT Number NCT07021599
Lead Sponsor Prince of Wales Hospital, Shatin, Hong Kong
Conditions Heart Failure
Enrollment 514 participants
Start Date 2025-07-01
Primary Completion 2028-07-03 (estimated)
Study Completion 2028-12-03 (estimated)
Updated on ClinicalTrials.gov 2025-06-15