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

No results posted yet for this study

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

  • AstraZeneca

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05859048 on ClinicalTrials.gov