Heart FailureNCT05791227
Safety and Efficacy Study of AI Wall Thickness Measurement (EchoNet-LVH-RCT)
A study testing Sonographer Evaluation and AI Evaluation in people with Heart Failure, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
To determine whether an integrated AI decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of AI guided measurements of wall thickness in parasternal long axis view compared to sonographer measurements in… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sonographer Evaluation and AI Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sonographers and cardiologists at CSMC Echocardiography Lab
- All transthoracic echocardiogram studies performed in the CSMC echocardiogram lab
Who cannot join
- transthoracic echocardiogram studies not able to be measured by sonographers in run in period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: EchoNet-LVH-RCT: Blinded, Randomized Controlled Trial of Artificial Intelligence Guided Precision Assessment of Wall Thickness
To determine whether an integrated AI decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of AI guided measurements of wall thickness in parasternal long axis view compared to sonographer measurements in preliminary readings of echocardiograms.
- Conditions
- Heart Failure
- Being tested
- Sonographer Evaluation, AI Evaluation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonographer EvaluationDiagnostic test
A sonographer will assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd).
AI EvaluationDiagnostic test
An AI model will assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd).
| Study group | Role | What they receive |
|---|---|---|
| Sonographer Annotation | Active comparator | Currently, sonographer technicians provide preliminary interpretations prior to validation and overreading by cardiologists. This staggered, stepwise evaluation allows for the introduction of AI decision support with minimal impact on patient care. Physicians are already used to adjusting the preliminary report given the variable training of sonographers and on the lookout for changes, variation, or adjustments that need to be made. Receives: Diagnostic Test: Sonographer Evaluation |
| Artificial Intelligence Annotation | Experimental | A novel AI algorithm developed to assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd). The AI will provide preliminary assessments for cardiologist evaluation. Receives: Diagnostic Test: AI Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.3cm for LVIDd
Proportion of significant difference in LVIDd between preliminary to final assessment
Measured: 10 Minutes
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for IVSd
Proportion of significant difference in IVSd between preliminary to final assessment
Measured: 10 Minutes
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for LVPWd
Proportion of significant difference in LVPWd between preliminary to final assessment
Measured: 10 Minutes
mean absolute error (MAE) of LVIDd between preliminary to overread between the two arms
Measurement difference of LVIDd between preliminary to final assessment
Measured: 10 Minutes
mean absolute error (MAE) of IVSd between preliminary to overread between the two arms
Measurement difference of IVSd between preliminary to final assessment
Measured: 10 Minutes
mean absolute error (MAE) of LVPWd between preliminary to overread between the two arms
Measurement difference of LVPWd between preliminary to final assessment
Measured: 10 Minutes
Secondary outcomes (3)
mean absolute error (MAE) of wall thickness between cardiologist overread vs. historical clinical report wall thickness
Mean absolute error (MAE) of wall thickness between cardiologist overread with initial interpretation vs. prior clinical report wall thickness
Measured: 10 Minutes
Time to complete each imaging study
Time for sonographers and cardiologists to complete a study (in seconds)
Measured: 10 Minutes
Effects of the AI systems integration with computer-human interaction (Blinding)
Whether cardiologists can tell the difference between human vs. AI initial interpretation (Bang's blinding index, or the proportion of studies guessed correctly to be AI or sonographer compared to ground truth of whether it was AI or sonographer).
Measured: 10 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Apr 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Studies will be randomized 1:1 to either sonographer preliminary report finding or AI preliminary report finding with final adjudication by the cardiologist. With AI preliminary report, the preliminary interpretations will be generated by AI (artificial intelligence) technology \[a semantic segmentation model\] and the PACS system's native reporting workflow will be used visualize measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd). The study team will assess how much cardiologists edit and change this preliminary interpretation is from the final interpretation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ouyang, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791227
- Sponsor's protocol ID
- STUDY00002521
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EchoNet-LVH-RCT: Blinded, Randomized Controlled Trial of Artificial Intelligence Guided Precision Assessment of Wall Thickness
- ClinicalTrials.gov ID
- NCT05791227
- Acronym / sponsor ID
- STUDY00002521
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether an integrated AI decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of AI guided measurements of wall thickness in parasternal long axis view compared to sonographer measurements in preliminary readings of echocardiograms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Studies will be randomized 1:1 to either sonographer preliminary report finding or AI preliminary report finding with final adjudication by the cardiologist. With AI preliminary report, the preliminary interpretations will be generated by AI (artificial intelligence) technology [a semantic segmentation model] and the PACS system's native reporting workflow will be used visualize measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd). The study team will assess how much cardiologists edit and change this preliminary interpretation is from the final interpretation.
| Arm | Type | Receives |
|---|---|---|
| Sonographer Annotation | Active comparator | Diagnostic Test: Sonographer EvaluationCurrently, sonographer technicians provide preliminary interpretations prior to validation and overreading by cardiologists. This staggered, stepwise evaluation allows for the introduction of AI decision support with minimal impact on patient care. Physicians are already used to adjusting the preliminary report given the variable training of sonographers and on the lookout for changes, variation, or adjustments that need to be made. |
| Artificial Intelligence Annotation | Experimental | Diagnostic Test: AI EvaluationA novel AI algorithm developed to assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd). The AI will provide preliminary assessments for cardiologist evaluation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sonographers and cardiologists at CSMC Echocardiography Lab
- All transthoracic echocardiogram studies performed in the CSMC echocardiogram lab
Key exclusion criteria (1 listed)
- transthoracic echocardiogram studies not able to be measured by sonographers in run in period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonographer EvaluationA sonographer will assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd). | Diagnostic test | Sonographer Annotation |
| AI EvaluationAn AI model will assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd). | Diagnostic test | Artificial Intelligence Annotation |
Primary outcome
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.3cm for LVIDd
Time frame: 10 Minutes
Proportion of significant difference in LVIDd between preliminary to final assessment
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for IVSd
Time frame: 10 Minutes
Proportion of significant difference in IVSd between preliminary to final assessment
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for LVPWd
Time frame: 10 Minutes
Proportion of significant difference in LVPWd between preliminary to final assessment
mean absolute error (MAE) of LVIDd between preliminary to overread between the two arms
Time frame: 10 Minutes
Measurement difference of LVIDd between preliminary to final assessment
mean absolute error (MAE) of IVSd between preliminary to overread between the two arms
Time frame: 10 Minutes
Measurement difference of IVSd between preliminary to final assessment
mean absolute error (MAE) of LVPWd between preliminary to overread between the two arms
Time frame: 10 Minutes
Measurement difference of LVPWd between preliminary to final assessment
3 secondary outcomes
mean absolute error (MAE) of wall thickness between cardiologist overread vs. historical clinical report wall thickness
Time frame: 10 Minutes
Time to complete each imaging study
Time frame: 10 Minutes
Effects of the AI systems integration with computer-human interaction (Blinding)
Time frame: 10 Minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonographer Evaluation and AI Evaluation in people with Heart Failure, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.3cm for LVIDd (time frame: 10 Minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.