Screening for early heart failure diagnosis and management using biomarkers and echocardiography
Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY
This study is testing a new way to find heart failure early in people over 40 who are at high risk by using blood tests and heart scans to see if it helps them get diagnosed and treated better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3904 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | NHS Greater Glasgow and Clyde Academic / other |
| Locations | 7 sites (Cleveland, Ohio and 6 other locations) |
| Trial ID | NCT05919342 on ClinicalTrials.gov |
What this trial studies
This international, multicentre, randomised-controlled trial aims to implement a targeted screening strategy to identify undiagnosed heart failure in high-risk patients aged 40 and older. Participants will be randomly assigned to either routine care or an investigational arm where they will undergo blood tests for NT-proBNP levels and echocardiography if elevated. The study will pool data from multiple countries, including Denmark, Canada, the USA, Sweden, and Scotland, to analyze the efficacy of this screening approach. The use of advanced echocardiography technology and AI-generated reports aims to enhance the accuracy of heart failure diagnosis.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older with two or more risk factors for heart failure, such as coronary artery disease or diabetes.
Not a fit: Patients without significant risk factors for heart failure or those under 40 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of heart failure, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using biomarkers and echocardiography for heart failure screening, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female ≥40 years of age * Informed consent * Two or more of the following risk factors for heart failure: 1. Coronary artery disease (either a previous documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis of an epicardial coronary artery \[50% left main stem or \>70% left anterior descending, circumflex or right coronary artery\]) 2. An established diagnosis of diabetes (type 1 or type 2) 3. Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation) 4. Previous ischemic or embolic stroke 5. Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel). 6. Chronic kidney disease (defined as an estimated glomerular filtration rate \<60mL/min/1.73m2 or eGFR 60-90mL/min/1.73m2 and UACR \>300mg/g). 7. Regular loop diuretic use (any dose at any dosing interval) for \>30 days. 8. COPD (evidenced by one of the following: PFTs showing airway obstruction, diagnosis by respiratory physician, CT scan reporting presence of emphysema or treatment with national guideline advocated COPD therapy). Exclusion Criteria: * Inability to give informed consent e.g., due to significant cognitive impairment * Previous documented diagnosis of heart failure * Current renal replacement therapy * Anyone who, in the investigators' 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
Cleveland, Ohio and 6 other locations
- Cleveland Clinic — Cleveland, Ohio, United States (Not_yet_recruiting)
- University of British Columbia — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- University of Montreal — Montreal, Quebec, Canada (Not_yet_recruiting)
- Rigshospitalet, Copenhagen University Hospital — Copenhagen, Denmark (Not_yet_recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Not_yet_recruiting)
- Uppsala University — Uppsala, Sweden (Not_yet_recruiting)
- University of Glasgow — Glasgow, Scotland, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Mark C Petrie, MbChB — University of Glasgow
- Study coordinator: Mark C Petrie, MbChB
- Email: mark.petrie@glasgow.ac.uk
- Phone: +44(0) 141 330 2677
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.