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NCT Number: NCT07624565

Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study

This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of AI-assisted point of care echocardiography on HF detection and downstream care processes for patients with suspected HF discharged from the Emergency Department.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Heart failure remains underdiagnosed in frontline care settings, in part due to limited access to timely echocardiography. Recent advances in artificial intelligence (AI)-assisted echocardiography may facilitate scalable bedside screening through automated image acquisition support and interpretation.

This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of routine implementation of AI-assisted point of care echocardiography on HF detection and downstream processes of care for patients with suspected HF being discharged from the Emergency Department.

This study will be carried out at 2 participating Emergency Departments (EDs) in Alberta, Canada. Each ED site will alternate monthly between Intervention (AI-assisted echocardiography) and Control (Usual Care) periods.

During intervention periods, patients with suspected HF will undergo AI-assisted echocardiography using a handheld point of care EchoNous Kosmos device by the treating ED physician. The US2.ai algorithm will generate an AI-automated echo report. During control periods, patients will be managed according to usual care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients age ≥18 years presenting to the emergency department (ED);
  • with signs or symptoms of HF as per the treating physician and
  • elevated natriuretic peptides (NT-proBNP >125pg/mL or BNP >50pg/mL), drawn as part of standard of care of evaluation in the ED.

Exclusion criteria

  • prior documented diagnosis of HF;
  • any patient receiving renal replacement therapy;
  • any patient receiving comfort or palliative care;
  • pregnant or nursing patients;
  • patient is planned for admission.

Treatment and study plan

AI-assisted point-of-care ultrasound (POCUS)

Device

ED physicians at both sites will be provided with 1 session of in person training in the use of the AI-assisted POCUS device within 4 weeks of randomization including,

  • Device set up
  • Demo of patient exam with POCUS device (to be used within its CE/Health Canada marked intended purpose or where deemed clinically appropriate by the treating physician).
  • Generation of AI-automated echocardiogram report for LVEF and diastolic dysfunction.

Primary outcomes

  1. Feasibility of AI Assisted Point of Care Echocardiography Implementation

    Time frame: During the enrollment period.

    Proportion of eligible patients successfully undergoing AI assisted echo assessment at the point of care.

Secondary outcomes

  1. Diagnosis of heart failure (HF) within 90 days

    Time frame: At 90 days.

  2. Downstream health care resource utilization at 90 days and 1 year (e.g. rates of requests for echocardiography, cardiology referral, primary care appointments, HF hospitalization).

    Time frame: At 90 days and 1 year.

  3. Proportion of patients with HF receiving GDMT within 90 days

    Time frame: At 90 days.

  4. Difference in ratio of the incidence of diagnoses of HF via hospital admission-based versus community-based pathways

    Time frame: At 90 days.

  5. Uptake and utilization: differential rates of uptake and utilization of AI Assisted echocardiography in the emergency department

    Time frame: During the enrollment period.

  6. Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire)

    Time frame: During the enrollment period.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Project Lead

CONTACT

[email protected]

1-800-707-9098

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian VIGOUR Centre

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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