Population-based Atrial Fibrillation Screening in Individuals With NT-proBNP Above Median in the Tromsø Study
PAFS-Tromsø
Atrial Fibrillation and Long Term ECG Monitoring of Heart Rhythm in the Tromsø Study
1 other identifier
interventional
4,000
1 country
2
Brief Summary
The aim is to investigate whether screening with long-term ECG monitoring in individuals with elevated NT-proBNP leads to a lower incidence of ischeamic stroke and death from vascular causes. The project is a sub-study within the 8th wave of the population based Tromsø Study. Information on previous diseases, medication use, and risk factors is collected through questionnaires, blood samples, and measurements of height, weight, blood pressure, and ECG. A total of 4,000 individuals with NT-proBNP levels above the median, without previously known atrial fibrillation (AF) or ongoing anticoagulation therapy, will be randomized to either long-term heart rhythm monitoring (7 days) or a control group without long-term ECG monitoring (2,000 in each group). Individuals with AF in the intervention group will be offered anticoagulation therapy in accordance with current guidelines. The intervention group and the control group will be compared with regards to incident stroke and death within a 6-year follow-up period. Information on endpoints and anticoagulation use will be obtained through linkage to national registries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2025
CompletedStudy Start
First participant enrolled
October 24, 2025
CompletedFirst Posted
Study publicly available on registry
January 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2035
January 15, 2026
July 1, 2025
6.4 years
July 21, 2025
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of participants with the composite outcome of ischemic stroke or cardiovascular death
Composite outcome of ischemic stroke and cardiovascular death
Within 6 years of screening
Number of participants with ischemic stroke
Ischemic stroke outcome
Within 6 years of screening
Number of participants with intracerebral hemorrhage
Intracerebral hemorrhage outcome
Within 6 years of screening
Number of participants with cardiovascular death
Cardiovascular death outcome
Within 6 years of screening
Secondary Outcomes (14)
Number of participants with atrial fibrillation
Within 14 days of screening
Duration of atrial fibrillation in hours
Within 14 days of screening
Left atrial volume index
Within 1 year of screening
Left atrial reservoir strain
Within 1 year of screening
Score on the 12-word immediate recall test
Within 6 years of screening
- +9 more secondary outcomes
Study Arms (2)
Intervention arm
EXPERIMENTALA total of 2000 individuals with NT-proBNP levels above the median, without previously known atrial fibrillation (AF) or ongoing anticoagulation therapy, will be randomized long-term heart rhythm monitoring using ECG247 (5-7 days). Individuals with AF in the intervention group will be offered anticoagulation therapy in accordance with current guidelines.
Control
NO INTERVENTIONThe control arm
Interventions
The AF screening device will be sent by post from the study centre to participants in the intervention group at inclusion, free-of-charge. User guides and a "help-desk" located at the University Hospital of North Norway will be available for phone/video assistance. Continuous ECG monitoring using the Norwegian produced ECG247 sensor will be performed for 5-7 days. Single lead ECG data is sent to a cloudbased server intermittently. The system stores information of ECG quality and is evaluated by trained algorithms which classify arrhythmias based on current criteria. All ECG recordings will be reviewed by a group of trained and experienced study nurses and physicians. In the event of clinically relevant arrhythmias, participants will be contacted as soon as possible and receive advice on follow-up with their general practitioner. Anticoagulation therapy and other treatments will be recommended if indicated according to current guidelines.
Eligibility Criteria
You may qualify if:
- Age ≥40 years
- NT-proBNP\> median level
- Informed consent for participation
You may not qualify if:
- History of AF (self-reported)
- Use of anticoagulation therapy
- Pacemaker/CRT device
- No available smart phone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Uit The Arctic University of Norway
Tromsø, 1902, Norway
University Hospital of North Norway Health Trust
Tromsø, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tor Ingenbrigtsen
University Hospital of North Norway
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2025
First Posted
January 15, 2026
Study Start
October 24, 2025
Primary Completion (Estimated)
March 1, 2032
Study Completion (Estimated)
March 1, 2035
Last Updated
January 15, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share