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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Stroke; Atrial Fibrillation (AF); NT-pro-BNP; Cognitive Function and Well-Being
• Intervention / Treatment: Diagnostic test: Long term heart rythm monitoring by ECG247

Detailed Description

This project has the potential for providing new knowledge related to the benefit of a stepwise screening approach for AF according to NT-proBNP level, utilizing a novel patch monitor with continuous ECG monitoring and automatic artificial intelligence based (AI) ECG analysis. The present project is planned as a sub-study of the epidemiological population-based Tromsø Study. In a randomized controlled clinical trial, we plan to test the primary hypothesis that in individuals with elevated NT-ProBNP who are diagnosed with AF through long-term ECG monitoring, anticoagulation treatment according to international guidelines will reduce the incidence of incident ischeamic stroke and cardiovascular death in the screening group compared to individuals who do not undergo screening (control group). The study will be performed within a well-defined cohort with extensive available longitudinal and cross-sectional information on risk factors and co-existing conditions. This setup facilitates addressing several knowledge gaps concerning risk stratification including associations between AF and echocardiographic parameters, cognitive impairment, structural changes on brain MRI, and HRQoL.

• Study Type: Interventional
• Enrollment (Estimated): 4000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnethe Eltoft, MD, PhD; Phone Number: +4797193417; Email: agnethe.eltoft@unn.no
• Study Contact Backup: Name: Emelia Gjesvik; Email: emelia.e.gjesvik@uit.no

Study Locations

• Norway
  • Tromsø, Norway, 1902
    • Recruiting
    • UiT The Arctic University of Norway
    • Contact: Agnethe Eltoft, MD, PhD; Phone Number: 004797193417; Email: agnethe.eltoft@uit.no
  • Tromsø, Norway
    • Recruiting
    • University Hospital of North Norway Health Trust
    • Contact: Agnethe Eltoft, MD, PhD; Email: agnethe.eltoft@unn.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; A 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.	Diagnostic test: Long term heart rythm monitoring by ECG247; 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.
No Intervention: Control; The control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with atrial fibrillation	Atrial fibrillation prevalence	Within 14 days of screening
Duration of atrial fibrillation in hours	Atrial fibrillation burden	Within 14 days of screening
Left atrial volume index	Echocardiographic measure	Within 1 year of screening
Left atrial reservoir strain	Echocardiographic measures	Within 1 year of screening
Score on the 12-word immediate recall test	Cognitive test performance outcome	Within 6 years of screening
Score on the Mini-Mental State Examination (MMS-E)	Cognitive test performance outcome	Within 6 years of screening
Score on the digit symbol coding test	Cognitive test performance outcome	Within 6 years of screening
Score on the HRQoL EuroQol-5 Dimension (EQ5D)	Health related quality of life (HRQoL) outcome	Within one year of screening
Score on the Whiteley Index	Health anxiety outcome	Within one year of screening
Global brain volume	Brain MRI measures	Within 2.5 years of screening
Segmental brain volume	Brain MRI measures	Within 2.5 years of screening
Volume of white matter lesions	Brain MRI measures	Within 2.5 years of screening
Number of clinical and subclinical infarcts	Brain MRI measures	Within 2.5 years of screening
Number og micro-hemorrhages	Brain MRI measures	Within 2.5 years of screening

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: UiT The Arctic University of Norway
• Investigators: Study Chair: Tor Ingenbrigtsen, University Hospital of North Norway

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2025
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2035

Study Registration Dates

• First Submitted: July 21, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure; Stroke; Atrial Fibrillation; Cognitive decline; Life Quality; ECG247; NT-Pro-BNP
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Neurocognitive Disorders; Cognition Disorders; Pathological Conditions, Signs and Symptoms; Stroke; Heart Failure; Cognitive Dysfunction; Atrial Fibrillation
• Other Study ID Numbers: 2025/856478 (REK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No