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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Number of participants with the composite outcome of ischemic stroke or cardiovascular death — Within 6 years of screening
  Composite outcome of ischemic stroke and cardiovascular death
• Number of participants with ischemic stroke — Within 6 years of screening
  Ischemic stroke outcome
• Number of participants with intracerebral hemorrhage — Within 6 years of screening
  Intracerebral hemorrhage outcome
• Number of participants with cardiovascular death — Within 6 years of screening
  Cardiovascular death outcome

Trial sites (2)

More University Hospital of North Norway trials in Norway

Other trials for the same condition