Improving early diagnosis of heart failure in high-risk Canadians
Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians
NA · Cardiology Research UBC · NCT05859048
This study is testing a new way to find heart failure earlier in high-risk Canadians by using advanced health records and special tests to see if it helps them get better care sooner.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1360 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Cardiology Research UBC (other) |
| Locations | 3 sites (Vancouver, British Columbia and 2 other locations) |
| Trial ID | NCT05859048 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the screening process for heart failure by utilizing an electronic health records (EHR) case finding algorithm, followed by N-Terminal pro-brain natriuretic peptide (NT-proBNP) screening and artificial intelligence (AI) echocardiography. Participants will be randomized into two groups: one receiving standard care and the other undergoing early heart failure testing. The intervention group will have their NT-proBNP levels tested, and those with elevated levels will receive further AI echocardiogram and ECG assessments. The goal is to identify patients at risk for heart failure earlier than the standard care approach, potentially improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals over 40 years old with at least two additional risk factors for heart failure.
Not a fit: Patients without any risk factors for heart failure or those under 40 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier diagnosis and treatment of heart failure, improving patient quality of life and outcomes.
How similar studies have performed: Other studies have shown promise in using similar screening approaches, indicating potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vancouver, British Columbia and 2 other locations
- Vancouver General Hospital — Vancouver, British Columbia, Canada (RECRUITING)
- Montreal Heart Institute — Montreal, Quebec, Canada (NOT_YET_RECRUITING)
- University of Sherbrooke — Sherbrooke, Quebec, Canada (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Nathaniel M Hawkins, MD — Associate Professor of Medicine, UBC Division of Cardiology
- Study coordinator: Naomi Uchida, BSN
- Email: naomi.uchida@ubc.ca
- Phone: 16048754521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Heart failure screening, natriuretic peptides, artificial intelligence echocardiography