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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06399666

Acronym

IERV

Enrollment

182

Registered

2024-05-06

Start date

2023-10-30

Completion date

2026-02-28

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Genetic Predisposition to Disease, Inflammation

Brief summary

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.

Interventions

OTHERBlood sampling

Blood sampling

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Recurrence of AF	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

Measure	Time frame	Description
Fluctuations of biomarkers and gene expression during follow-up	During follow-up (post ECV, day 7, 30, 90, and 180)	Change in biomarker level or expression of gene expressions during follow-up.

Countries

Sweden

Contacts

Primary ContactJakob Hytting, MD

jakob.hytting@liu.se+46 + 707679724

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026