Identification of Immunomodulators Associated With Atrial Fibrillation Reporting: Analysis of the WHO Pharmacovigilance Database

Sponsor

University Hospital, Caen (Other)

Overall Status

Completed

CT.gov ID

NCT06095791

Collaborator

(none)

4,000,000

Enrollment

Location

Actual Duration (Months)

3927419.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Atrial fibrillation is the most prevalent sustained arrhythmia worldwide with a great morbimortality. Some populations are more at risk to develop atrial fibrillation like patients suffering from inflammatory diseases or patients suffering from cancers. This is at least explained by the inflammatory environment related to these both conditions. Many experimental studies and clinical studies support the role of inflammation and immunity in atrial fibrillation genesis by modulating atrial action potential et by promoting fibrosis.

Immunomodulators are drugs used to stimulate or inhibit the immune system for two main indications : cancers and immune disorder diseases which both promote atrial fibrillation. Due to their interactions with inflammation and immunity, immunomodulatores may further promote the risk of atrial fibrillation, particularly in a population already at risk.

Based on the World Health Organization global database, the main objective of this study is to investigate the association between immunomodulators and the occurrence of atrial fibrillation reported in the database.

A disproportionality analysis will be performed. It will aim to assess whether immunomodulators are associated with a greater risk of atrial fibrillation.

Secondary objectives aim to describe the cases of atrial fibrillation among immunomodulators associated with atrial fibrillation in the main analysis, to describe coprescription among immunomodulators associated with atrial fibrillation in the main analysis, to analyse the role of immunomoduloators medical indication in the overrisk of atrial fibrillation, and to try to highlight some immune mechanisms promoting atrial fibrillation regarding the immunomodulators associated with atrial fibrillation in the main analysis.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Immunomodulators with FDA approval on the 1st January 2023.

Study Design

Study Type:

Observational

Actual Enrollment :

4000000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Identification of Immunomodulators Associated With Atrial Fibrillation Reporting: Analysis of the WHO Pharmacovigilance Database

Actual Study Start Date :

Aug 1, 2022

Actual Primary Completion Date :

Sep 1, 2022

Actual Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

Association between atrial fibrillation and immunomodulators [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022]
A disproportionality analysis is carried out in multivariate analysis taking into account cofounding factors (factors known to promote atrial fibrillation).

Secondary Outcome Measures

Descriptive analysis of the atrial fibrillation cases with immunomodulators significantly associated with atrial fibrillation in the primary analysis [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022]
The investigators describe the profile of cases of atrial fibrillation among immunomodulators associated with atrial fibrillation in the main analysis. We particularly focused on factors known to promote atrial fibrillation.
Identification of molecular/cellular pathway through mechanism of action of immunomodulators associated with AF in the primary analysis. [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022]
The aim is to suggest a physiopathology model focused on the role of immune system in atrial fibrillation genesis by taking into account the state of knowledge and the mechanisms suggested by the immunomodulators associated with atrial fibrillation in the main analysis.
Exploratory analysis: association between immunomodulators medical indication and atrial fibrillation. [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022]
Descriptive analysis of the coprescription between immunomodulators associated with atrial fibrillation in the main analysis. [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/09/2022
Patients treated with FDA approved immunomodulators (approval the 1st January 2023).