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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
View:

• Age ≥40 years

• NT-proBNP\> median level

• Informed consent for participation

Locations
Other Locations
Norway
Uit The Arctic University of Norway
RECRUITING
Tromsø
University Hospital of North Norway Health Trust
RECRUITING
Tromsø
Contact Information
Primary
Agnethe Eltoft, MD, PhD
agnethe.eltoft@unn.no
+4797193417
Backup
Emelia Gjesvik
emelia.e.gjesvik@uit.no
Time Frame
Start Date: 2025-10-24
Estimated Completion Date: 2035-03-01
Participants
Target number of participants: 4000
Treatments
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.
No_intervention: Control
The control arm
Sponsors
Leads: University Hospital of North Norway
Collaborators: UiT The Arctic University of Norway

This content was sourced from clinicaltrials.gov