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NCT Number: NCT07343895

Population-based Atrial Fibrillation Screening in Individuals With NT-proBNP Above Median 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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Cognitive Function and Well-Being Heart Diseases Heart Failure Mental Disorders NT-pro-BNP Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uit The Arctic University of Norway, Tromsø, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Long term heart rythm monitoring by ECG247

Diagnostic Test

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.

Primary outcomes

  1. Number of participants with the composite outcome of ischemic stroke or cardiovascular death

    Time frame: Within 6 years of screening

    Composite outcome of ischemic stroke and cardiovascular death

  2. Number of participants with ischemic stroke

    Time frame: Within 6 years of screening

    Ischemic stroke outcome

  3. Number of participants with intracerebral hemorrhage

    Time frame: Within 6 years of screening

    Intracerebral hemorrhage outcome

  4. Number of participants with cardiovascular death

    Time frame: Within 6 years of screening

    Cardiovascular death outcome

Secondary outcomes

  1. Number of participants with atrial fibrillation

    Time frame: Within 14 days of screening

    Atrial fibrillation prevalence

  2. Duration of atrial fibrillation in hours

    Time frame: Within 14 days of screening

    Atrial fibrillation burden

  3. Left atrial volume index

    Time frame: Within 1 year of screening

    Echocardiographic measure

  4. Left atrial reservoir strain

    Time frame: Within 1 year of screening

    Echocardiographic measures

  5. Score on the 12-word immediate recall test

    Time frame: Within 6 years of screening

    Cognitive test performance outcome

  6. Score on the Mini-Mental State Examination (MMS-E)

    Time frame: Within 6 years of screening

    Cognitive test performance outcome

  7. Score on the digit symbol coding test

    Time frame: Within 6 years of screening

    Cognitive test performance outcome

  8. Score on the HRQoL EuroQol-5 Dimension (EQ5D)

    Time frame: Within one year of screening

    Health related quality of life (HRQoL) outcome

  9. Score on the Whiteley Index

    Time frame: Within one year of screening

    Health anxiety outcome

  10. Global brain volume

    Time frame: Within 2.5 years of screening

    Brain MRI measures

  11. Segmental brain volume

    Time frame: Within 2.5 years of screening

    Brain MRI measures

  12. Volume of white matter lesions

    Time frame: Within 2.5 years of screening

    Brain MRI measures

  13. Number of clinical and subclinical infarcts

    Time frame: Within 2.5 years of screening

    Brain MRI measures

  14. Number og micro-hemorrhages

    Time frame: Within 2.5 years of screening

    Brain MRI measures

Study contacts

Contact information is provided by the study sponsor or research team.

Agnethe Eltoft, MD, PhD

CONTACT

[email protected]

+4797193417

Emelia Gjesvik

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • UiT The Arctic University of Norway

Registry information

Official study title

Atrial Fibrillation and Long Term ECG Monitoring of Heart Rhythm in the Tromsø Study

Acronym: PAFS-Tromsø

Important dates

Study start
2025
Primary completion
2032
Study completion
2035
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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