NCT07021599Active, not recruiting
Artificial Intelligence Versus Sonographer Echocardiogram Analysis and Reporting in Patients With Heart Failure
Artificial Intelligence Versus Sonographer Echocardiogram Analysis and Reporting in Patients With Heart Failure: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 514 (estimated)
- First submitted
- 5 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 3 Jul 2028
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Diseases
- Heart failure
- NCT number
- NCT07021599
What you commit to
- Study type: Interventional
- Planned participants: 514
- From 1 Jul 2025 to the primary completion date, 3 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Known severe valvular heart disease
Other
- Insufficient image quality for proper analysis determined by the scanning sonographer (estimated to be 15% of all echocardiograms screened)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.