Life sciences · Interventional Study
ClinicalTrials.gov · September 16, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07021599). This is a study registration, not published results. Lead sponsor: Prince of Wales Hospital, Shatin, Hong Kong. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 514 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DIAGNOSTIC_TEST: Tailored AI echocardiogram analysis and reporting system. Primary outcome measures: Rate of complete agreement in LVEF assessments , 6 month; Rate of complete agreement in assessments of AS severity , 6 month; Rate of complete agreement in assessment of MR severity , 6 month. Brief 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.