About this trial
Because of the high recurrence rates following electrical cardioversion and high morbidity in AF patients there is a need to explore prediction models for AF recurrence following ECV. Previous studies have primarily focused on high-sensitivity CRP (hsCRP), CRP, and IL-6, while other inflammatory indexes and gene scores might hold greater value.
This prospective cohort study is planning to include 182 patients with persistent atrial fibrillation, planned for electrical cardioversion, and \>18 years at two medium-sized hospitals in Sweden. Blood samples will be collected prior to electrical cardioversion and at 7-, 30-, 90-, and 180-days follow-up. Atrial fibrillation recurrence will be evaluated at follow-up or upon patient request and diagnosed with 12-lead ECG.
An interim analysis will be conducted after more than 80 patients have been included. If the results from univariate and/or multivariable logistic regression on inflammatory markers and genetic expression regarding atrial fibrillation recurrence are significant, the study will be concluded.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Persistent atrial fibrillation (ICD-10 I48.1)
Age over 18 years
Disqualifiers
Autoimmune disease
Inflammatory diseases
Acute or chronic liver dysfunction
Ongoing infectious diseases
Trial population
The study included patients aged 18 or older diagnosed with persistent atrial fibrillation (ICD-10 I48.1) scheduled for ECV. Inclusion took place from 2023-10-18 to 2025-06-01.
Trial design
Cohort
Prospective
Treatments tested in this trial
Blood sampling
Other interventionBlood sampling
Treatment groups
Trial outcomes
Primary outcomes
Recurrence of AF
Recurrence of atrial fibrillation or atrial flutter recorded on 12-lead ECG or through pacemaker interpretation
Secondary outcomes
Fluctuations of biomarkers and gene expression during follow-up
Change in biomarker level or expression of gene expressions during follow-up.
Sponsors and contacts
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Vrinnevi Hospital
Lead sponsor
Ryhov County Hospital
Collaborator