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Clinical Trials in Canada / NCT05859048
Recruiting Not applicable

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

NCT05859048 · tracked via the Priya Life Science Canada tracker
Sponsor
Cardiology Research UBC
Phase
Not applicable
Started
2024-03-01
Last updated
2024-03-07

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

NT-proBNPAI echocardiogramelectrocardiogramCardiovascular physical examination

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)

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

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female \> 40 years of age * 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: * 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.

Primary outcome measure(s)

  • Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines — enrollment to six months
    Incidence of HF diagnosis in outpatient settings Urgent heart failure visit. Heart failure hospitalization.
  • Number of outpatient HF visits — enrollment to six months
    Number of outpatient visits for HF with initiation or intensification of oral HF therapy
  • Number of urgent HF visit — enrollment to six months
    Incidence of HF presentation in urgent care setting with administration of intravenous HF therapies
  • Number of HF hospitalizations — enrollment to six months
    Number of admission for HF

Trial sites (3)

FacilityCityRegionStatus
Vancouver General Hospital Vancouver British Columbia Recruiting
Montreal Heart Institute Montreal Quebec Not Yet Recruiting
University of Sherbrooke Sherbrooke Quebec Not Yet Recruiting

More Cardiology Research UBC trials in Canada

Canadian SCAD Study Recruiting
Observing the Role of Inflammation in Peripheral Artery Disease and Its Impact on Heart and Mobility Health: PANACEA-O. Recruiting
Spot Analysis of Natriuresis to Guide up- or Down-titration of Diuretic Therapy in Ambulatory Patients With Chronic Heart Failure Recruiting

Other trials for the same condition

Predicting Readmissions Using Omics, Biostatistical Evaluate and Artificial Intelligence Recruiting
The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis Recruiting
COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease Recruiting
The iPeer2Peer Mentorship Program for Young Adults With Heart Disease Starting soon
A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05859048 on ClinicalTrials.gov ↗ ← All trials in Canada