CClinicalTrials.gg
RecruitingNCT05558605AGILE-EchoUpdated Sep 30, 2026

Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment

An interventional study of AI-guided echo and Standard echo in Heart Failure and Valve Heart Disease, sponsored by Baker Heart and Diabetes Institute. Recruiting at 1 site in Australia. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Baker Heart and Diabetes Institute · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
612
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Heart Failure
  • Valve Heart Disease

Keywords

  • Artificial intelligence
  • Echocardiography
  • Heart failure
  • Valve disease
03

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age >45 years
  • eligible for Medicare
  • exercise intolerance or cardiovascular (CV) risk factors

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
612 participants (estimated)

Study arms

  • Experimental
    Screening/Management Plan

    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.

    Diagnostic Test: AI-guided echo

  • Active comparator
    Usual care

    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.

    Diagnostic Test: Standard echo

Interventions

  • Diagnostic testAI-guided echo

    AI-guided echocardiography

  • Diagnostic testStandard echo

    Standard echocardiography

05

What researchers measure

Primary outcomes

  1. Diagnosis of cardiac dysfunction or heart valve disease

    Number of Participants with Diagnosis of cardiac dysfunction or heart valve disease

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
  • Alice Springs Hospital
    Alice Springs, Northern Territory, Australia
    • Angus Baumann, MD · Contact
    Recruiting
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 19, 2022
  • Informed consent form · Jul 19, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05558605
Lead sponsor
Baker Heart and Diabetes Institute
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
First posted
Sep 28, 2022
Start date
Feb 24, 2023
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Tom Marwick, MBBS, PhD
Contact
tom.marwick@baker.edu.au
+61385321550
Tom Marwick, MBBS, PhD
principal investigator · Baker Heart and Diabetes Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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