Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure
NCT05859048 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1360
Last updated 2024-03-07
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
Conditions
Interventions
- DIAGNOSTIC_TEST
-
NT-proBNP
blood sample to measure N-terminal prohormone of B-type natriuretic peptide at local laboratory
- DIAGNOSTIC_TEST
-
AI echocardiogram
Artificial intelligence driven transthoracic echocardiogram
- DIAGNOSTIC_TEST
-
electrocardiogram
tracing of electrical cardiac activity of the heart
- OTHER
-
Cardiovascular physical examination
basic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg)
Sponsors & Collaborators
- collaborator INDUSTRY
-
Centre for Cardiovascular Innovation
collaborator UNKNOWN -
NHS Greater Glasgow & Clyde
collaborator UNKNOWN -
HeartLife Foundation
collaborator UNKNOWN -
Canadian Heart Function Alliance
collaborator UNKNOWN -
Montreal Heart Institute
collaborator OTHER -
Cardiology Research UBC
lead OTHER
Principal Investigators
-
Nathaniel M Hawkins, MD · Associate Professor of Medicine, UBC Division of Cardiology
-
Anique Ducharme, MD · Professor of Medicine, Univeriste de Montreal, Montreal Heart Institute
-
Serge LePage, MD · Centre Hospitalier Universite de Sherbrooke-Hopital Fleurimont
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-01
- Primary Completion
- 2027-01-01
- Completion
- 2029-01-01
Countries
- Canada
Study Locations
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