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

NCT07624565 | Not Yet Recruiting

• 1 other identifier: A2I2HF
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart Failure (HF); Emergency Department (ED); Point of Care Ultrasound; AI-assisted echocardiography

Outcome Measures

Primary Outcomes (1)

• Feasibility of AI Assisted Point of Care Echocardiography Implementation

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

  During the enrollment period.

Secondary Outcomes (6)

• Diagnosis of heart failure (HF) within 90 days

  At 90 days.

• 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).

  At 90 days and 1 year.

• Proportion of patients with HF receiving GDMT within 90 days

  At 90 days.

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

  At 90 days.

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

  During the enrollment period.

Study Arms (2)

Intervention

EXPERIMENTAL

During each month-long Intervention period, an AI-assisted POCUS tool will be available for ED physicians use, at their discretion, to assess left ventricular ejection fraction (LVEF) and diastolic function in patients presenting to the ED with suspected HF. The AI-automated echocardiogram report may be used in the referral pathway to the HF clinic if deemed clinically appropriate.

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

Control Period (Usual Care)

NO INTERVENTION

During each month-long Control period, the ED physicians will manage patients as close to "true" usual care as possible. There is no "placebo" arm. No actions will be undertaken to impede or prohibit care in the usual care arm.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients age ≥18 years presenting to the 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, OR age≥ 40 years and ≥1 HF risk factor:
• Established diagnosis of type 2 diabetes
• Coronary artery disease (prior documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis of an epicardial coronary artery (\>50% left main or \>70% left anterior descending, circumflex or right coronary artery)
• Previous ischemic or embolic stroke
• Peripheral artery disease (previous surgical or percutaneous revascularization or a documented stenosis greater than 50% of a major peripheral arterial vessel).
• Regular loop diuretic use

You may not qualify if:

• prior documented diagnosis of HF;
• any patient receiving renal replacement therapy;
• any patient receiving comfort or palliative care;
• pregnant or nursing patients;
• patients planned for admission
• Investigator/treating physician discretion: any patient not suitable for participation for other reasons

Sponsors & Collaborators

• Canadian VIGOUR Centre: collaborator
• University of Alberta: lead

MeSH Terms

Conditions

Heart Failure; Emergencies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Safia Chatur, MD

  Massachusetts General Hospital/Harvard Medical School and University of Alberta

  PRINCIPAL INVESTIGATOR

• Justin Ezekowitz, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Project Lead

CONTACT

1-800-707-9098; aa2i2@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study utilizes a time-sequential randomization structure, alternating monthly between control (standard care) and intervention (AI Assisted Echocardiography) periods. Patients will be consecutively enrolled based on their presentation during the assigned period, with no crossover within a given time block.

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 3, 2026
• Study Start: September 29, 2026
• Primary Completion (Estimated): November 29, 2027
• Study Completion (Estimated): November 28, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09