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Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians
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
Heart failure describes a chronic condition where the heart muscle is no longer able to supply the body with enough oxygen and nutrients. This can lead to fatigue and poor quality of life. Often, people do not know they have heart failure until they end up in hospital. This study wants to improve the screening of heart failure and identify patients at risk for heart failure earlier. This will help determine if early-screening and treatment can help prevent further decline in these patients. This is a randomized, un-blinded study comparing usual care to an intervention group receiving early heart failure testing. Pre-screening will be performed using extracted primary care electronic health records with the case finding algorithm based on the inclusion and exclusion criteria. An invitation letter will be send to prospective patients which include a registration telephone number and link to dedicated study website. The invitation for contact will adopt an "opt out" approach (ask the potential participant to contact the coordinating centre if they do not wish to be contacted). Potential participants not opting out, or opting in, within 2 weeks of invitation mailing will be sent a patient information package along with follow up contact by research team. Consented participants will be randomized either to usual care or interventions group and followed for six months. Intervention group will have NT-proBNP drawn and those with an elevated NT-proBNP (\>125pg/mL) will have a study visit with assessments to include, physical examination, electrocardiogram and study AI echocardiogram.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Vancouver General Hospital
Vancouver, British Columbia, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
University of Sherbrooke
Sherbrooke, Quebec, Canada
Start Date
March 1, 2024
Primary Completion Date
January 1, 2027
Completion Date
January 1, 2029
Last Updated
March 7, 2024
1,360
ESTIMATED participants
NT-proBNP
DIAGNOSTIC_TEST
AI echocardiogram
DIAGNOSTIC_TEST
electrocardiogram
DIAGNOSTIC_TEST
Cardiovascular physical examination
OTHER
Lead Sponsor
Cardiology Research UBC
Collaborators
NCT07484009
NCT07191730
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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