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NCT Number: NCT06399666

Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Heart Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical department, Jönköping, Småland, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood sampling

Other

Blood sampling

Primary outcomes

  1. Recurrence of AF

    Time frame: During follow-up (post ECV, day 7, 30, 90, and 180)

    Recurrence of atrial fibrillation or atrial flutter recorded on 12-lead ECG or through pacemaker interpretation

Secondary outcomes

  1. Fluctuations of biomarkers and gene expression during follow-up

    Time frame: During follow-up (post ECV, day 7, 30, 90, and 180)

    Change in biomarker level or expression of gene expressions during follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Jakob Hytting, MD

CONTACT

[email protected]

+46 + 707679724

Sponsors and collaborators

Lead sponsor

Vrinnevi Hospital

Other

Collaborators

  • Ryhov County Hospital

Registry information

Official study title

Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation - IERV Trial

Acronym: IERV

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 6, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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