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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorCardiology Research UBC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female > 40 years of age

Informed consent

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NT-proBNP

    Diagnostic test

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

  • AI echocardiogram

    Diagnostic test

    Artificial intelligence driven transthoracic echocardiogram

  • electrocardiogram

    Diagnostic test

    tracing of electrical cardiac activity of the heart

  • Cardiovascular physical examination

    Other intervention

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

Treatment groups

1,360 Participants
are divided into 2 treatment groups
Group A: Investigational arm guided by NT-proBNP resultActive comparator 4 interventions
Group B: Routine care armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines

Incidence of HF diagnosis in outpatient settings Urgent heart failure visit. Heart failure hospitalization.

Time frame
enrollment to six months
2

Number of outpatient HF visits

Number of outpatient visits for HF with initiation or intensification of oral HF therapy

Time frame
enrollment to six months
3

Number of urgent HF visit

Incidence of HF presentation in urgent care setting with administration of intravenous HF therapies

Time frame
enrollment to six months
4

Number of HF hospitalizations

Number of admission for HF

Time frame
enrollment to six months

Secondary outcomes

1

incidence of prescription for guideline recommended HF therapies in patients diagnosed with HFrEF

number of diagnosis of HF with reduced Ejection Fraction (HFrEF) within 6 months. Patients diagnosed with HFrEF receiving Guideline-directed medical therapy within 6 months

Time frame
enrollment to six months
2

HF events in HFrEF

number of HF admissions

Time frame
enrollment to six months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cardiology Research UBC

Lead sponsor

AstraZeneca

Collaborator

Centre for Cardiovascular Innovation

Collaborator

NHS Greater Glasgow & Clyde

Collaborator

HeartLife Foundation

Collaborator

Canadian Heart Function Alliance

Collaborator

Montreal Heart Institute

Collaborator