RecruitingNot ApplicableNCT05859048

Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure

Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians


Sponsor

Cardiology Research UBC

Enrollment

1,360 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 Years

Inclusion Criteria11

  • 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 Criteria4

  • 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.

Interventions

DIAGNOSTIC_TESTNT-proBNP

blood sample to measure N-terminal prohormone of B-type natriuretic peptide at local laboratory

DIAGNOSTIC_TESTAI echocardiogram

Artificial intelligence driven transthoracic echocardiogram

DIAGNOSTIC_TESTelectrocardiogram

tracing of electrical cardiac activity of the heart

OTHERCardiovascular physical examination

basic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg)


Locations(3)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

University of Sherbrooke

Sherbrooke, Quebec, Canada

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NCT05859048


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