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

October 17, 2023 updated by: University Hospital, Caen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse Normandie
      • Caen, Basse Normandie, France, 14000
        • Alexandre Joachim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Every patients in the World Health Organization (WHO) database of individual safety case reports to 01/09/2022 included with at least one immunomodulator.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between atrial fibrillation and immunomodulators
Time Frame: 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).
Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive analysis of the atrial fibrillation cases with immunomodulators significantly associated with atrial fibrillation in the primary analysis
Time Frame: 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.
Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022
Identification of molecular/cellular pathway through mechanism of action of immunomodulators associated with AF in the primary analysis.
Time Frame: 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.
Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022
Exploratory analysis: association between immunomodulators medical indication and atrial fibrillation.
Time Frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022
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.
Time Frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022
Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CaenUH_JF_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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