About this trial
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.
Eligibility criteria
Qualifiers
Aged 18 years or above
Has new or worsening of heart failure symptoms
Elevated heart failure blood markers (N-terminal prohormone of brain natriuretic peptide, "NTproBNP") within 3 months from enrolment or by point-of-care blood test, to ensure that the patient's symptoms are cardiac origin
Provision of written informed consent
Disqualifiers
Known severe valvular heart disease
Prior prosthetic valve implantation
Previously known or suspected >=severe tricuspid regurgitation, >=moderate aortic regurgitation, >=moderate mitral stenosis or pericardial disease during detected during image acquisition
Insufficient image quality for proper analysis determined by the scanning sonographer (estimated to be 15% of all echocardiograms screened)
Trial design
Treatments tested in this trial
- Tailored AI echocardiogram analysis and reporting system