NCT05859048

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,360 (estimated)
• Sponsor: Cardiology Research UBC · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2023-05-15
• Last updated: 2024-03-07

Locations

3 sites across 1 country: Canada