About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Individuals who have underwent Holter recording at Danderyd hospital after 2022.
Trial design
Cohort
Prospective
Treatments tested in this trial
Holter recording
Diagnostic testHolter recording with Zenicor Flex ECG during 14 days.
Echocardiography (Echo)
Diagnostic testEchocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.
Blood sample
Diagnostic testBlood 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.
24 hour ambulatory blood pressure monitoring And Arteriograph
Diagnostic testTo assess artery stiffness.
Treatment groups
Trial outcomes
Primary outcomes
atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA.
Proportion of patients with at least one episode of atrial fibrillation with a duration of at least 30 seconds among patients with ESVEA on Holter recording as compared to patients without ESVEA.
Secondary outcomes
the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation.
Presence of paroxysmal or permanent atrial fibrillation on follow-up.
Temporal development of ESVEA and atrial cardiomyopathy on repeated Holter recordings.
Comparison of burden of supraventricular extrasystolic beats and number of episodes and duration of longest episode of supraventricular tachycardia.
Temporal development of several blood biomarkers with a possible relation to atrial cardiomyopathy in patients with and without ESVEA.
Explorative sequential analysis of several blood biomarkers using PEA:
association between plasma biomarkers and the development of atrial fibrillation in patients with ESVEA.
Comparison of biomarker profile in patients diagnosed with atrial fibrillation and patients not diagnosed with atrial fibrillation.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Danderyd Hospital
Collaborator