Atrial fibrillation screening for people with higher-than-median NT-proBNP in Tromsø
Atrial Fibrillation and Long Term ECG Monitoring of Heart Rhythm in the Tromsø Study
NA · University Hospital of North Norway · NCT07343895
This will test whether giving 7-day wearable ECG monitoring to people aged 40+ with NT-proBNP above the median can find atrial fibrillation and reduce ischemic stroke and vascular deaths compared with no long-term monitoring.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 4000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University Hospital of North Norway (other) |
| Locations | 2 sites (Tromsø and 1 other locations) |
| Trial ID | NCT07343895 on ClinicalTrials.gov |
What this trial studies
This randomized sub-study within the Tromsø population cohort will enroll 4,000 participants with NT-proBNP above the median and no prior AF or anticoagulation, randomizing 2,000 to 7-day continuous ECG monitoring with the ECG247 patch and AI-based analysis and 2,000 to usual care without long-term monitoring. Participants in whom AF is detected will be offered anticoagulation according to current international guidelines. The primary comparison is incident ischemic stroke and cardiovascular death between the screened and unscreened groups over follow-up. Extensive baseline data from the Tromsø Study will allow analyses of associations with echocardiographic measures, brain MRI changes, cognition, and quality of life.
Who should consider this trial
Good fit: Adults aged 40 years or older with NT-proBNP above the population median, no known atrial fibrillation, not on anticoagulation, and willing to provide informed consent are ideal candidates.
Not a fit: People with known AF, those already taking anticoagulants, those with pacemaker/CRT devices, or those without a smartphone (or with NT-proBNP at or below the median) are not eligible and unlikely to benefit from this screening strategy.
Why it matters
Potential benefit: If successful, this approach could detect otherwise-hidden AF earlier and lower the risk of ischemic stroke and vascular death by directing appropriate anticoagulation.
How similar studies have performed: Prolonged ECG monitoring is known to increase AF detection in other studies, but whether screening reduces stroke is still uncertain and using NT-proBNP as a prescreening step is a relatively new, less-tested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥40 years * NT-proBNP\> median level * Informed consent for participation Exclusion Criteria: * History of AF (self-reported) * Use of anticoagulation therapy * Pacemaker/CRT device * No available smart phone
Where this trial is running
Tromsø and 1 other locations
- Uit The Arctic University of Norway — Tromsø, Norway (RECRUITING)
- University Hospital of North Norway Health Trust — Tromsø, Norway (RECRUITING)
Study contacts
- Study coordinator: Agnethe Eltoft, MD, PhD
- Email: agnethe.eltoft@unn.no
- Phone: +4797193417
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: Atrial Fibrillation, Stroke, NT-pro-BNP, Cognitive Function and Well-Being, Heart Failure, ECG247, NT-Pro-BNP, Cognitive decline