Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians
Trial ID: NCT05859048
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-03-01
Completion date: 2029-01-01
Sponsor: Cardiology Research UBC
Collaborators: AstraZeneca; Centre for Cardiovascular Innovation; NHS Greater Glasgow & Clyde; HeartLife Foundation; Canadian Heart Function Alliance; Montreal Heart Institute
Conditions: Heart Failure
Interventions: NT-proBNP; AI echocardiogram; electrocardiogram; Cardiovascular physical examination
Locations: Vancouver General Hospital; Montreal Heart Institute; University of Sherbrooke
Countries: Canada; Canada; Canada
Enrollment: 1360
Age range: 40 Years - None
Sex: ALL

Summary:
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:
Inclusion Criteria:

* Male or female \> 40 years of age
* Informed consent
* At least two additional risk factors for Heart Failure (HF):

  * 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.
  * Persistent or permanent atrial fibrillation.
  * Previous ischemic or embolic stroke.
  * Peripheral artery disease (previous surgical or percutaneous revascularization or documented stenosis \>50% of major peripheral arterial vessel.
  * Chronic kidney disease (defined as an estimated glomerular filtration rate (eGFR)\<60 milliliters per minute (mL/min)/1.73m2 or eGFR 60-90 mL/min/1.73m2 and urine albumin-creatinine ration (UACR) \>300mg/g).
  * Regular loop diuretic use for \>30 days within 12 months prior to consent.
  * Chronic obstructive pulmonary disease (COPD) evidenced by one of the following: Pulmonary Function Test (PFT) showing airway obstruction, diagnosis of respiratory physician, CT scan reporting presence of emphysema, or treatment with national guidance advocated COPD therapy.

Exclusion Criteria:

* 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.

Outcomes:
Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines; Number of outpatient HF visits; Number of urgent HF visit; Number of HF hospitalizations