Heart FailureAGILE-EchoNCT05558605
Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment
A study testing AI-guided echo and Standard echo in people with Heart Failure and Valve Heart Disease, run by Baker Heart and Diabetes Institute at 1 site in Australia.
Trial summary
Heart Failure and valvular heart disease are disproportionate problems in rural and remote Australia (RRA). Echocardiography is the best imaging investigation, and essential for management, but access to this essential test shows huge geographic variations, primarily because of dependence on expert acquisition. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Heart Failure, Valve Heart Disease
- What is being tested?
- AI-guided echo and Standard echo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Feb 2023to 30 Jun 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >45 years
- eligible for Medicare
- exercise intolerance or cardiovascular (CV) risk factors
Who cannot join
- Known HF or HVD
- situations where cardio-protection is already indicated (eg. known CAD)
- comorbid conditions with life expectancy <2 years
- inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Alice Springs Hospital
Alice Springs, Northern Territory
Angus Baumann, MD
About this study
Heart Failure and valvular heart disease are disproportionate problems in rural and remote Australia (RRA). Echocardiography is the best imaging investigation, and essential for management, but access to this essential test shows huge geographic variations, primarily because of dependence on expert acquisition. This trial seeks to demonstrate the effectiveness of artificial intelligence-based echocardiography for triage and management of patients with known or suspected heart disease in RRA.
Read the detailed description
Heart Failure (HF) and valvular heart disease (VHD) are disproportionate problems in rural and remote Australia (RRA) relative to the rest of the country, due in part to an ageing rural population and to the frequency of rheumatic heart disease in the Aboriginal community. Late diagnoses can lead to avoidable hospital admissions and expense to the Australian health system. Echocardiography is the imaging investigation of choice, and a cornerstone of management, but access to this essential test shows huge geographic variations in Australia. The primary reason for this is the dependence of this technique on expert acquisition. Artificial intelligence (AI) has now been harnessed to optimise echocardiographic image acquisition, and secure, cloud-based storage enables remote measurement and interpretation. This trial seeks to demonstrate the effectiveness of AI-based echocardiography-guided triage and management of patients with known or suspected heart disease in RRA. This study will involve the conduct of a world-first randomised controlled trial of AI-testing and early intervention to detect early stages of HF and VHD, select appropriate management, reduce admissions and preserve functional status and quality of life. The study will be conducted with partipants in RRA, aged 40 years and older with at least one HF risk factor and recruited through clinic and community outreach in four sites with the involvement of remote outreach from i) Alice Springs Hospitals, ii) Nepean Hospital to Dubbo Hospital and Western NSW, iii) Princess Alexandra Hospital to Roma, Charleville and Western Queensland, and iv) Perth Aboriginal communities in partnership with the Royal Perth hospital and the Derbarl Yerrigan Health Service. Approximately 1200 individuals at risk for HF and VHD will be screened and followed up. The study will be conducted in partnership with Aboriginal community partners.
- Conditions
- Heart Failure, Valve Heart Disease
- Being tested
- AI-guided echo, Standard echo
- Keywords
- Artificial intelligence, Echocardiography, Heart failure, Valve disease
- Medical subject headings
- Heart Failure, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-guided echoDiagnostic test
AI-guided echocardiography
Standard echoDiagnostic test
Standard echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Screening/Management Plan | Experimental | AI-guided echo acquisition performed using a desktop echo machine (uSmart 3300, Terason, Burlington, MA) with AI software (Caption Health, Brisbane, CA) obtained by a non-expert (eg. clinic nurse, registrar general practitioner or physician) at the remote clinic, usually on the day of clinic review. Images will then be uploaded onto a secure cloud and downloaded at the core lab for measurement, interpretation and reporting. Receives: Diagnostic Test: AI-guided echo |
| Usual care | Active comparator | Standard echo acquisition by a sonographer either at a referral hospital, or by a visiting team - usually necessitating a delay. Measurement, interpretation and reporting will happen as usual. Receives: Diagnostic Test: Standard echo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of cardiac dysfunction or heart valve disease
Number of Participants with Diagnosis of cardiac dysfunction or heart valve disease
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start24 Feb 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 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.
- 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
- Multicentre RCT comparing AI-TTE with usual care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Alice Springs Hospital, Princess Alexandra Hospital, Brisbane, Australia, Royal Perth Hospital, Ochre Health, Walgett Aboriginal Medical Services, Merriden Health Service, Royal Hobart Hospital, Quairading Medical Practice
- Responsible party
- Sponsor
- Investigators
- Tom Marwick, MBBS, PhD, Principal investigator, Baker Heart and Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558605
- Sponsor's protocol ID
- 325-22
- Acronym
- AGILE-Echo
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment
- ClinicalTrials.gov ID
- NCT05558605
- Acronym / sponsor ID
- AGILE-Echo / 325-22
- Conditions
- Heart Failure, Valve Heart Disease
- Keywords
- Artificial intelligence, Echocardiography, Heart failure, Valve disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Collaborators
- Alice Springs Hospital, Princess Alexandra Hospital, Brisbane, Australia, Royal Perth Hospital, Ochre Health, Walgett Aboriginal Medical Services, Merriden Health Service, Royal Hobart Hospital, Quairading Medical Practice
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Sep 2022 (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 and valvular heart disease are disproportionate problems in rural and remote Australia (RRA). Echocardiography is the best imaging investigation, and essential for management, but access to this essential test shows huge geographic variations, primarily because of dependence on expert acquisition. This trial seeks to demonstrate the effectiveness of artificial intelligence-based echocardiography for triage and management of patients with known or suspected heart disease in RRA.
Detailed description
Heart Failure (HF) and valvular heart disease (VHD) are disproportionate problems in rural and remote Australia (RRA) relative to the rest of the country, due in part to an ageing rural population and to the frequency of rheumatic heart disease in the Aboriginal community. Late diagnoses can lead to avoidable hospital admissions and expense to the Australian health system. Echocardiography is the imaging investigation of choice, and a cornerstone of management, but access to this essential test shows huge geographic variations in Australia. The primary reason for this is the dependence of this technique on expert acquisition. Artificial intelligence (AI) has now been harnessed to optimise echocardiographic image acquisition, and secure, cloud-based storage enables remote measurement and interpretation. This trial seeks to demonstrate the effectiveness of AI-based echocardiography-guided triage and management of patients with known or suspected heart disease in RRA. This study will involve the conduct of a world-first randomised controlled trial of AI-testing and early intervention to detect early stages of HF and VHD, select appropriate management, reduce admissions and preserve functional status and quality of life. The study will be conducted with partipants in RRA, aged 40 years and older with at least one HF risk factor and recruited through clinic and community outreach in four sites with the involvement of remote outreach from i) Alice Springs Hospitals, ii) Nepean Hospital to Dubbo Hospital and Western NSW, iii) Princess Alexandra Hospital to Roma, Charleville and Western Queensland, and iv) Perth Aboriginal communities in partnership with the Royal Perth hospital and the Derbarl Yerrigan Health Service. Approximately 1200 individuals at risk for HF and VHD will be screened and followed up. The study will be conducted in partnership with Aboriginal community partners.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre RCT comparing AI-TTE with usual care
| Arm | Type | Receives |
|---|---|---|
| Screening/Management Plan | Experimental | Diagnostic Test: AI-guided echoAI-guided echo acquisition performed using a desktop echo machine (uSmart 3300, Terason, Burlington, MA) with AI software (Caption Health, Brisbane, CA) obtained by a non-expert (eg. clinic nurse, registrar general practitioner or physician) at the remote clinic, usually on the day of clinic review. Images will then be uploaded onto a secure cloud and downloaded at the core lab for measurement, interpretation and reporting. |
| Usual care | Active comparator | Diagnostic Test: Standard echoStandard echo acquisition by a sonographer either at a referral hospital, or by a visiting team - usually necessitating a delay. Measurement, interpretation and reporting will happen as usual. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >45 years
- eligible for Medicare
- exercise intolerance or cardiovascular (CV) risk factors
Key exclusion criteria (4 listed)
- Known HF or HVD
- situations where cardio-protection is already indicated (eg. known CAD)
- comorbid conditions with life expectancy <2 years
- inability to provide written informed consent
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 |
|---|---|---|
| AI-guided echoAI-guided echocardiography | Diagnostic test | Screening/Management Plan |
| Standard echoStandard echocardiography | Diagnostic test | Usual care |
Primary outcome
Diagnosis of cardiac dysfunction or heart valve disease
Time frame: 12 months
Number of Participants with Diagnosis of cardiac dysfunction or heart valve disease
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 30 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Tom Marwick, MBBS, PhD principal investigator
Baker Heart and Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-guided echo and Standard echo in people with Heart Failure and Valve Heart Disease, run by Baker Heart and Diabetes Institute at 1 site in Australia.
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 3 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 30 Sep 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 Australia. 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 Tom Marwick, MBBS, PhD (+61385321550, tom.marwick@baker.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of cardiac dysfunction or heart valve disease (time frame: 12 months). 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 30 Sep 2026.