Heart FailureNCT07624565
Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study
A study testing AI-assisted point-of-care ultrasound (POCUS) in people with Heart Failure, run by University of Alberta.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- AI-assisted point-of-care ultrasound (POCUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2026to 28 Nov 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- AI-assisted point-of-care ultrasound (POCUS)
- Keywords
- Heart Failure (HF), Emergency Department (ED), Point of Care Ultrasound, AI-assisted echocardiography
- Medical subject headings
- Heart Failure, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of AI Assisted Point of Care Echocardiography Implementation
Proportion of eligible patients successfully undergoing AI assisted echo assessment at the point of care.
Measured: During the enrollment period.
Secondary outcomes (6)
Diagnosis of heart failure (HF) within 90 days
Measured: 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).
Measured: At 90 days and 1 year.
Proportion of patients with HF receiving GDMT within 90 days
Measured: At 90 days.
Difference in ratio of the incidence of diagnoses of HF via hospital admission-based versus community-based pathways
Measured: At 90 days.
Uptake and utilization: differential rates of uptake and utilization of AI Assisted echocardiography in the emergency department
Measured: During the enrollment period.
Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire)
Measured: During the enrollment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start29 Sep 2026 (estimated)
- Primary completion29 Nov 2027 (estimated)
- Study completion28 Nov 2028 (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
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian VIGOUR Centre
- Responsible party
- Sponsor
- Investigators
- Safia Chatur, MD, Principal investigator, Massachusetts General Hospital/Harvard Medical School and University of AlbertaJustin Ezekowitz, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624565
- Sponsor's protocol ID
- A2I2HF
- Status last verified
- Sep 2026
- First submitted
- 25 May 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study
- ClinicalTrials.gov ID
- NCT07624565
- Acronym / sponsor ID
- A2I2HF
- Conditions
- Heart Failure
- Keywords
- Heart Failure (HF), Emergency Department (ED), Point of Care Ultrasound, AI-assisted echocardiography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian VIGOUR Centre
- Study start
- 29 Sep 2026 (estimated)
- Primary completion
- 29 Nov 2027 (estimated)
- Study completion
- 28 Nov 2028 (estimated)
- First posted
- 3 Jun 2026 (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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: AI-assisted point-of-care ultrasound (POCUS)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
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-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. | Device | Intervention |
Primary outcome
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.
6 secondary outcomes
Diagnosis of heart failure (HF) within 90 days
Time frame: 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).
Time frame: At 90 days and 1 year.
Proportion of patients with HF receiving GDMT within 90 days
Time frame: At 90 days.
Difference in ratio of the incidence of diagnoses of HF via hospital admission-based versus community-based pathways
Time frame: At 90 days.
Uptake and utilization: differential rates of uptake and utilization of AI Assisted echocardiography in the emergency department
Time frame: During the enrollment period.
Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire)
Time frame: During the enrollment period.
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 9 Sep 2026.
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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.
Safia Chatur, MD principal investigator
Massachusetts General Hospital/Harvard Medical School and University of Alberta
Justin Ezekowitz, MD principal investigator
University of Alberta
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted point-of-care ultrasound (POCUS) in people with Heart Failure, run by University of Alberta.
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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Clinical Trials Project Lead (1-800-707-9098, aa2i2@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of AI Assisted Point of Care Echocardiography Implementation (time frame: During the enrollment period.). 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 9 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.