NCT04593498

Excessive Supraventricular Activity and Atrial Fibrillation

Detection of Atrial Fibrillation in Patients With Excessive Supraventricular Activity

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 70 Years – 89 Years
• Healthy volunteers: Accepted

Summary

The aim of the proposed study is to determine if individuals with excessive supraventricular ectopic activity (ESVEA) on Holter recording should be subjected to prolonged screening with Event loop recorder in order to detect previously undiagnosed Atrial fibrillation / flutter. Other biomarkers such as plasma biomarkers, high-end echocardiography and assessment of blood pressure and atrial stiffness will be studied and compared in ESVEA and control group as well as progression of atrial cardiomyopathy in ESVEA patients.

Detailed description

Excessive supraventricular ectopic activities (ESVEA) are a common finding on long-term ECG recordings and have a connection to atrial cardiomyopathy, incident AF, stroke and mortality. Holter recording from 2022 preformed at Danderyd hospital will be screened in order to identify 125 recordings with ESVEA, defined as at least 30 atrial ectopic beats/hour or a supraventricular run of at least 20 consecutive beats. Participants fulfilling eligibility criteria will be offered prolonged AF screening with continuous holter recording during 14 days. A matched control group (125 participants) without ESVEA will also be screened using same method. Cardiovascular data from medical records will be collected in order to obtain information regarding co-morbidities and being able to assess CHA2DS2-VASC score. Participants will be asked to fill in a questionnaire. Samples of blood will be collected at index time, after 21± 3 months for further analysis with the aim of identifying biomarkers for atrial fibrillation. During these two time periods echocardiography, 24 hour ambulatory blood pressure monitoring and assessment af artery stiffness with Arteriograph will also be preformed. The study population will after 21± 3 months be subjected to renewed screening with Holter in order to examine the persistence of excessive supraventricular activity. Four years after the completion of screening visits, data from patient records and information thorough telephone interview and/or data from Swedish Patient Register, Swedish Dispensed Drug Register will be collected

Conditions

• Atrial Fibrillation
• Atrial Flutter
• Supraventricular Beat, Premature
• Premature Supraventricular Beats
• Premature Atrial Complex
• Extrasystole, Atrial

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Holter recording	Holter recording with Zenicor Flex ECG during 14 days.
DIAGNOSTIC_TEST	Echocardiography (Echo)	Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.
DIAGNOSTIC_TEST	Blood sample	Blood sample: 2 x 10 ml EDTA plasma sampled from venous blood at index and at 21 months. Troponin T, NTproBNP, Na, K, Creatinine. Sample for Biobank for future analysis.
DIAGNOSTIC_TEST	24 hour ambulatory blood pressure monitoring And Arteriograph	To assess artery stiffness.

Timeline

• Start date: 2022-11-01
• Primary completion: 2026-12-31
• Completion: 2028-02-15
• First posted: 2020-10-20
• Last updated: 2024-03-06

Locations

1 site across 1 country: Sweden