Heart FailureREFERENCE-AINCT07701369
Relevance of Artificial Intelligence-Assisted Echocardiography for Left Ventricular Ejection Fraction Assessment in Geriatric Patients
A study testing AutoEF-AI Assessment and Standard Echocardiography (Reference method) in people with Heart Failure, run by Gérond'if at 1 site in France.
Trial summary
Heart failure (HF) is the leading cause of hospitalization among adults aged 80 years and older and represents a major diagnostic challenge in geriatric medicine due to frequently atypical clinical presentations and the presence of multiple comorbidities. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- AutoEF-AI Assessment and Standard Echocardiography (Reference method)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2026to 30 Jun 2028
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥75 years.
- Hospitalization in a geriatric unit for acute heart failure according to the 2021 ESC diagnostic criteria.
- Hemodynamic stability at the time of echocardiographic examination.
- Ability to understand study information, provide written informed consent, and willingness to participate.
- Affiliation with, or beneficiary of, a health insurance/social security scheme.
Who cannot join
- Hemodynamic instability preventing echocardiographic assessment.
- Contraindication to transthoracic echocardiography.
- Patients under legal protection (guardianship, curatorship, or judicial protection measures) or unable to provide informed consent.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Broca Hospital
Paris, 75013
Olivier HANON, MD PHD, 01 44 08 33 81, olivier.hanon@aphp.fr
About this study
Heart failure (HF) is the leading cause of hospitalization among adults aged 80 years and older and represents a major diagnostic challenge in geriatric medicine due to frequently atypical clinical presentations and the presence of multiple comorbidities. Although transthoracic echocardiography (TTE) with measurement of left ventricular ejection fraction (LVEF) remains the gold standard for cardiac functional assessment, access to echocardiography is often limited in geriatric wards.
Recent advances in artificial intelligence (AI) have enabled the development of portable ultrasound devices and automated image analysis software capable of providing reliable and reproducible LVEF measurements. AI-assisted automated LVEF assessment (AutoEF-AI) may therefore represent a valuable alternative to conventional echocardiography for the cardiac evaluation of older patients with heart failure.
Read the detailed description
Prospective, single-center interventional study comparing two methods of left ventricular ejection fraction measurement in patients aged 75 years and older hospitalized for acute heart failure.Each hemodynamically stable participant will undergo two echocardiographic examinations performed within 24 hours:
- Standard Echocardiography (Reference Method)
- AI-assisted automated LVEF assessment (AutoEF-AI)
- Conditions
- Heart Failure
- Being tested
- AutoEF-AI Assessment, Standard Echocardiography (Reference method)
- Keywords
- Heart failure, Artificial Intelligence-Assisted Echocardiography, Artificial Intelligence, Echocardiography, Left Ventricular Ejection Fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoEF-AI AssessmentDiagnostic test
Performed by a geriatrician who has completed a one-day practical training session and combines:
- A handheld ultrasound device providing real-time image acquisition guidance for obtaining apical views.
- Us2.ai software for automated LVEF analysis. The geriatrician is blinded to results of the gold standard echocardiography performed by the cardiologist.
Standard Echocardiography (Reference method)Diagnostic test
The standard echocardiography will be performed by an expert cardiologist as part of routine clinical care and will serve as the gold standard
| Study group | Role | What they receive |
|---|---|---|
| Standard Echocardiography (Reference method) | Other | The standard echocardiography will be performed by a cardiologist as part of routine clinical care. Receives: Diagnostic Test: Standard Echocardiography (Reference method) |
| AutoEF-AI Assessment | Experimental | AI-assisted automated LVEF assessment Receives: Diagnostic Test: AutoEF-AI Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between LVEF measured using AutoEF-AI and LVEF measured using standard echocardiography.
Agreement will be assessed using:
- Intraclass Correlation Coefficient (ICC)
- Spearman correlation coefficient
- Bland-Altman analysis
- Weighted kappa coefficient for the classification of patients according to LVEF categories (≤40%, 41-49%, and ≥50%)
Measured: At baseline
Secondary outcomes (3)
Diagnostic performance of AutoEF-AI for the detection of LVEF <50%, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.
Calculation of the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy of AutoEF-AI for identifying left ventricular ejection fraction (LVEF) below 50%, compared with the standard reference method.
Measured: At baseline
Analysis of factors associated with agreement between the two methods
Multiple linear regression model will be used to identify clinical and technical variables (age, sex, cardiovascular history, presence of a pacemaker, cardiac arrhythmias, image quality, comorbidities, etc.) associated with a significant discrepancy between LVEF measurements obtained using AutoEF-AI and standard echocardiography.
Measured: At baseline
Feasibility of AutoEF-AI use by a geriatrician after a short training program
- Success rate of valid image acquisition (i.e acquizition of analyzable apical views suitable for automated analysis)
- Quality of the acquired images (image quality score and proportion of non-analyzable images)
- Difficulties encountered during the use of the AutoEF-AI device
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start7 Jul 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (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.
- 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Agreement between LVEF measured using AutoEF-AI and LVEF measured using standard echocardiography
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier HANON, MD PhD, Principal investigator, Geriatric Department, Broca hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701369
- Sponsor's protocol ID
- 2025-A02039-40
- Acronym
- REFERENCE-AI
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Artificial Intelligence-Assisted Echocardiography for Left Ventricular Ejection Fraction Assessment in Geriatric Patients
- ClinicalTrials.gov ID
- NCT07701369
- Acronym / sponsor ID
- REFERENCE-AI / 2025-A02039-40
- Conditions
- Heart Failure
- Keywords
- Heart failure, Artificial Intelligence-Assisted Echocardiography, Artificial Intelligence, Echocardiography, Left Ventricular Ejection Fraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 14 Jul 2026 (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.
Heart failure (HF) is the leading cause of hospitalization among adults aged 80 years and older and represents a major diagnostic challenge in geriatric medicine due to frequently atypical clinical presentations and the presence of multiple comorbidities. Although transthoracic echocardiography (TTE) with measurement of left ventricular ejection fraction (LVEF) remains the gold standard for cardiac functional assessment, access to echocardiography is often limited in geriatric wards.
Recent advances in artificial intelligence (AI) have enabled the development of portable ultrasound devices and automated image analysis software capable of providing reliable and reproducible LVEF measurements. AI-assisted automated LVEF assessment (AutoEF-AI) may therefore represent a valuable alternative to conventional echocardiography for the cardiac evaluation of older patients with heart failure.
Detailed description
Prospective, single-center interventional study comparing two methods of left ventricular ejection fraction measurement in patients aged 75 years and older hospitalized for acute heart failure.Each hemodynamically stable participant will undergo two echocardiographic examinations performed within 24 hours:
- Standard Echocardiography (Reference Method)
- AI-assisted automated LVEF assessment (AutoEF-AI)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Agreement between LVEF measured using AutoEF-AI and LVEF measured using standard echocardiography
| Arm | Type | Receives |
|---|---|---|
| Standard Echocardiography (Reference method) | Other | Diagnostic Test: Standard Echocardiography (Reference method)The standard echocardiography will be performed by a cardiologist as part of routine clinical care. |
| AutoEF-AI Assessment | Experimental | Diagnostic Test: AutoEF-AI AssessmentAI-assisted automated LVEF assessment |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥75 years.
- Hospitalization in a geriatric unit for acute heart failure according to the 2021 ESC diagnostic criteria.
- Hemodynamic stability at the time of echocardiographic examination.
- Ability to understand study information, provide written informed consent, and willingness to participate.
- Affiliation with, or beneficiary of, a health insurance/social security scheme.
Key exclusion criteria (4 listed)
- Hemodynamic instability preventing echocardiographic assessment.
- Contraindication to transthoracic echocardiography.
- Patients under legal protection (guardianship, curatorship, or judicial protection measures) or unable to provide informed consent.
- Refusal to participate in the study.
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 |
|---|---|---|
| AutoEF-AI AssessmentPerformed by a geriatrician who has completed a one-day practical training session and combines: * A handheld ultrasound device providing real-time image acquisition guidance for obtaining apical views. * Us2.ai software for automated LVEF analysis. The geriatrician is blinded to results of the gold standard echocardiography performed by the cardiologist. | Diagnostic test | AutoEF-AI Assessment |
| Standard Echocardiography (Reference method)The standard echocardiography will be performed by an expert cardiologist as part of routine clinical care and will serve as the gold standard | Diagnostic test | Standard Echocardiography (Reference method) |
Primary outcome
Agreement between LVEF measured using AutoEF-AI and LVEF measured using standard echocardiography.
Time frame: At baseline
Agreement will be assessed using: * Intraclass Correlation Coefficient (ICC) * Spearman correlation coefficient * Bland-Altman analysis * Weighted kappa coefficient for the classification of patients according to LVEF categories (≤40%, 41-49%, and ≥50%)
3 secondary outcomes
Diagnostic performance of AutoEF-AI for the detection of LVEF <50%, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.
Time frame: At baseline
Analysis of factors associated with agreement between the two methods
Time frame: At baseline
Feasibility of AutoEF-AI use by a geriatrician after a short training program
Time frame: At baseline
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 28 Jul 2026.
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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.
Olivier HANON, MD PhD principal investigator
Geriatric Department, Broca hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoEF-AI Assessment and Standard Echocardiography (Reference method) in people with Heart Failure, run by Gérond'if at 1 site in France.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 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 France. 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?
Contact Isabelle DUFOUR (+33 (0) 185781011, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between LVEF measured using AutoEF-AI and LVEF measured using standard echocardiography. (time frame: At baseline). 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 28 Jul 2026.