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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: AI-assisted point-of-care ultrasound (POCUS)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Project Lead; Phone Number: 1-800-707-9098; Email: aa2i2@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patients age ≥18 years presenting to the emergency department (ED);
2. with signs or symptoms of HF as per the treating physician and
3. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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); 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.
No Intervention: Control Period (Usual Care); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.
Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire)	During the enrollment period.

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Canadian VIGOUR Centre
• Investigators: Principal Investigator: Justin Ezekowitz, MD, University of Alberta; Principal Investigator: Safia Chatur, MD, Massachusetts General Hospital/Harvard Medical School and University of Alberta

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 14, 2028

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Emergency Department (ED); Heart Failure (HF); Point of Care Ultrasound; AI-assisted echocardiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Pathological Conditions, Signs and Symptoms; Heart Failure; Emergencies
• Other Study ID Numbers: A2I2HF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No