Optimising a Digital Diagnostic Pathway for Heart Failure in the Community

Study Overview
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Brief Summary
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This is a prospective, observational study. The primary aim is to assess the diagnostic accuracy of Artificial Intelligence (AI) analysis of Point of Care (POC) handheld transthoracic echocardiogram images (POC handheld echocardiogram) compared to the current gold-standard of transthoracic echocardiogram images acquired and analysed by a British Society of Echocardiography (BSE) accredited operator, using a standard echocardiogram machine (standard TTE), for the diagnosis of Heart Failure with reduced Ejection Fraction (HFrEF), in patients referred from the community for investigation of suspected new Heart Failure (HF).

Detailed Description
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Demonstrate that in comparison to using the current gold standard of BSE accredited operator echocardiography within a HFDP, using AI enhanced analysis of POC handheld echocardiography is accurate and safe. This has the potential to improve access to timelier echocardiography in order to achieve earlier HF diagnosis and treatment, which is known to delay/prevent progression to HF hospitalisation. It will also provide useful information regarding the future feasibility of using AI enhanced analysis of POC handheld echocardiography in the community, for investigation of people with suspected new HF. Facilitate the digitisation of an NHS Heart Failure diagnostic service in order to standardise and improve the quality of data collection and clinical care provided within the service.

Official Title
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Optimising a Digital Diagnostic Pathway for Heart Failure in the Community

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: Echocardiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult individuals referred from the community who are awaiting HF diagnostic investigations, including echocardiography, to investigate for a suspected new diagnosis of HF Exclusion Criteria: Individuals less than 18 years of age Individuals who have had an interim echocardiogram for another clinical reason, whilst on the outpatient echocardiogram waiting list for investigation of HF Individuals with a previous ICD-10 diagnosis of HF in any coding position Inability of the participant, in the opinion of the investigators, to understand and/or comply with study procedures, or any conditions that, in the opinion of the investigators, may render the participant unable to understand, attend and/or undergo study visit investigations Inability to read and understand the PIS (provided in English only), and understand the research team

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Referred from primary care for investigation of suspected heart failure<br>All patients recruited to the OPERA trial will have been referred from their primary care clinician for investigation of a suspected diagnosis of heart failure. | Diagnostic Test: Echocardiogram<br>* Echocardiography plays a crucial role in the diagnosis of HF; it is the standard of care imaging modality used to confirm the diagnosis, it permits real-time imaging of the heart and quantitative assessment of cardiac structure and function, crucial for diagnosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative and positive predictive value (NPV and PPV) | NPV and PPV describe the proportions of postive and negative results that are true results | 1 day | 
| False positive | A results that wrongly indicates heart failure is present in the OPERA patient | 1 day | 
| False negative | A result that wrongly indicates heart failure is not present in the OPERA patient | 1 day | 
| sensitivity | the ability of a diagnostics test to correctly identify those with heart failure | 1 day | 
| specificity | the ability of a diagnostic test to correctly identify those without heart failure | 1 day | 
| Area under curve | area under receiver operator curve comparison of the standard TTE Vs AI analysed POC echocardiogram for the diagnosis of HFrEF in people referred from the community for investigation of suspected new HF | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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echocardiogram, NTproBNP, digital diagnosis