About this trial
The goal of this study is improve the screening of heart failure and identify patients early who are at risk of heart failure.
The main question\[s\] it aims to answer are:
• will an electronic health records (EHR) case finding algorithm for heart failure, followed by N-Terminal pro-brain natriuretic peptide (NT-proBNP) screening and artificial intelligence (AI) echocardiogram compared to usual care identify patients at risk for heart failure earlier than standard of care?
Participants will be enrolled and randomized to either standard of care (SOC) or intervention arm:
SOC arm: electronic health records will be reviewed over six months for assessments performed to identify heart failure.
Intervention arm: blood sample for N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) at local laboratory . For elevated NT-proBNP results (\>125pg/ml) an artificial intelligence (AI) echocardiogram and 12 lead electrocardiogram (ECG) will be performed at study site (within 28 days of NT-proBNP result). EHR will be reviewed at six months
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female > 40 years of age
Informed consent
Coronary artery disease (either a previous documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis or an epicardial coronary artery (50% left main stem or >70% left anterior descending, circumflex or right coronary artery)).
Diabetes type 1 or 2.
Disqualifiers
Inability to give informed consent (e.g. due to significant cognitive impairment).
Previous diagnosis of heart failure. This is any diagnosis of heart failure with any ejection fraction of any cause.
Renal replacement therapy.
Anyone who, in the investigator's opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period.
Trial design
Parallel
Treatments tested in this trial
NT-proBNP
Diagnostic testblood sample to measure N-terminal prohormone of B-type natriuretic peptide at local laboratory
AI echocardiogram
Diagnostic testArtificial intelligence driven transthoracic echocardiogram
electrocardiogram
Diagnostic testtracing of electrical cardiac activity of the heart
Cardiovascular physical examination
Other interventionbasic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg)
Treatment groups
Trial outcomes
Primary outcomes
Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines
Incidence of HF diagnosis in outpatient settings Urgent heart failure visit. Heart failure hospitalization.
Number of outpatient HF visits
Number of outpatient visits for HF with initiation or intensification of oral HF therapy
Number of urgent HF visit
Incidence of HF presentation in urgent care setting with administration of intravenous HF therapies
Number of HF hospitalizations
Number of admission for HF
Secondary outcomes
incidence of prescription for guideline recommended HF therapies in patients diagnosed with HFrEF
number of diagnosis of HF with reduced Ejection Fraction (HFrEF) within 6 months. Patients diagnosed with HFrEF receiving Guideline-directed medical therapy within 6 months
HF events in HFrEF
number of HF admissions
Sponsors and contacts
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Cardiology Research UBC
Lead sponsor
AstraZeneca
Collaborator
Centre for Cardiovascular Innovation
Collaborator
NHS Greater Glasgow & Clyde
Collaborator
HeartLife Foundation
Collaborator
Canadian Heart Function Alliance
Collaborator
Montreal Heart Institute
Collaborator