Population-based Atrial Fibrillation Screening in Individuals With NT-proBNP Above Median in the Tromsø Study

NCT ID: NCT07343895

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-24
• Study Completion Date: 2035-03-01

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.

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.

Conditions

Atrial Fibrillation (AF); Stroke; NT-pro-BNP; Cognitive Function and Well-Being; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Long term heart rythm monitoring by ECG247

Intervention Type: 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.

Control

The control arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UiT The Arctic University of Norway

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tor Ingenbrigtsen

Role: STUDY_CHAIR

University Hospital of North Norway

Locations

Uit The Arctic University of Norway

Tromsø, , Norway

Site Status: RECRUITING

University Hospital of North Norway Health Trust

Tromsø, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Agnethe Eltoft, MD, PhD

Role: CONTACT

agnethe.eltoft@unn.no

+4797193417

Emelia Gjesvik

Role: CONTACT

emelia.e.gjesvik@uit.no

Facility Contacts

Agnethe Eltoft, MD, PhD

Role: primary

agnethe.eltoft@uit.no

004797193417

Agnethe Eltoft, MD, PhD

Role: primary

agnethe.eltoft@unn.no

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2025/856478 (REK)

Identifier Type: -

Identifier Source: org_study_id