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Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation (IERV)

V

Vrinnevi Hospital

Status

Enrolling

Conditions

Inflammation
Atrial Fibrillation
Genetic Predisposition to Disease

Treatments

Other: Blood sampling

Study type

Observational

Funder types

Other

Identifiers

NCT06399666
Dnr 2023-02252-01

Details and patient eligibility

About

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.

Enrollment

182 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Persistent atrial fibrillation (ICD-10 I48.1)
  • Age over 18 years

Exclusion criteria

  • Autoimmune disease
  • Inflammatory diseases
  • Acute or chronic liver dysfunction
  • Ongoing infectious diseases
  • Thyroid disorders
  • Any other conditions known to impact inflammatory activity (including medication use and hematological diseases)

Trial design

182 participants in 1 patient group

Prospective cohort
Description:
Prospective cohort measuring the previously described biomarkers.
Treatment:
Other: Blood sampling

Trial contacts and locations

2

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Central trial contact

Jakob Hytting, MD

Data sourced from clinicaltrials.gov

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