Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure
NCT ID: NCT05859048
Last Updated: 2024-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1360 participants
INTERVENTIONAL
2024-03-01
2029-01-01
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Investigational arm guided by NT-proBNP result
NT-proBNP drawn and if level elevated (\>125 pg/ml) a study visit with artificial intelligence (AI) echocardiogram, electrocardiogram (ECG), and heart failure (HF) focused examination conducted
NT-proBNP
blood sample to measure N-terminal prohormone of B-type natriuretic peptide at local laboratory
AI echocardiogram
Artificial intelligence driven transthoracic echocardiogram
electrocardiogram
tracing of electrical cardiac activity of the heart
Cardiovascular physical examination
basic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg)
Routine care arm
Participants will be remotely monitored for number of heart failure events
No interventions assigned to this group
Interventions
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NT-proBNP
blood sample to measure N-terminal prohormone of B-type natriuretic peptide at local laboratory
AI echocardiogram
Artificial intelligence driven transthoracic echocardiogram
electrocardiogram
tracing of electrical cardiac activity of the heart
Cardiovascular physical examination
basic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Centre for Cardiovascular Innovation
UNKNOWN
NHS Greater Glasgow & Clyde
UNKNOWN
HeartLife Foundation
UNKNOWN
Canadian Heart Function Alliance
UNKNOWN
Montreal Heart Institute
OTHER
Cardiology Research UBC
OTHER
Responsible Party
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Nathaniel Hawkins
Principal Investigator
Principal Investigators
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Nathaniel M Hawkins, MD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor of Medicine, UBC Division of Cardiology
Anique Ducharme, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Medicine, Univeriste de Montreal, Montreal Heart Institute
Serge LePage, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universite de Sherbrooke-Hopital Fleurimont
Locations
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Vancouver General Hospital
Vancouver, British Columbia, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
University of Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MAPLE-CHF
Identifier Type: -
Identifier Source: org_study_id
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