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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Montreal Heart Institute
NOT_YET_RECRUITING
Montreal
University of Sherbrooke
NOT_YET_RECRUITING
Sherbrooke
Vancouver General Hospital
RECRUITING
Vancouver
Contact Information
Primary
Naomi Uchida, BSN
naomi.uchida@ubc.ca
16048754521
Backup
Jennifer Petterson
jenny.petterson@vch.ca
604-875-5104
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 1360
Treatments
Active_comparator: 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
No_intervention: Routine care arm
Participants will be remotely monitored for number of heart failure events
Related Therapeutic Areas
Sponsors
Collaborators: NHS Greater Glasgow & Clyde, Centre for Cardiovascular Innovation, Canadian Heart Function Alliance, AstraZeneca, Montreal Heart Institute, HeartLife Foundation
Leads: Cardiology Research UBC

This content was sourced from clinicaltrials.gov