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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06095791
• Other study ID #: CaenUH_JF_1
• Status: Completed
• Start date: August 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000000
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Immunomodulators with FDA approval on the 1st January 2023.
Disproportionnality analysis studying the association between immunomodulators with FDA approval on the 1st January 2023 and atrial fibrillation in the World Health Organization pharmacovigilance database.

Locations

Country	Name	City	State
France	Alexandre Joachim	Caen	Basse Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (4)

Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fi — View Citation

Guo Y, Lip GY, Apostolakis S. Inflammation in atrial fibrillation. J Am Coll Cardiol. 2012 Dec 4;60(22):2263-70. doi: 10.1016/j.jacc.2012.04.063. — View Citation

Lazzerini PE, Capecchi PL, Laghi-Pasini F. Systemic inflammation and arrhythmic risk: lessons from rheumatoid arthritis. Eur Heart J. 2017 Jun 7;38(22):1717-1727. doi: 10.1093/eurheartj/ehw208. — View Citation

Lazzerini PE, Laghi-Pasini F, Acampa M, Srivastava U, Bertolozzi I, Giabbani B, Finizola F, Vanni F, Dokollari A, Natale M, Cevenini G, Selvi E, Migliacci N, Maccherini M, Boutjdir M, Capecchi PL. Systemic Inflammation Rapidly Induces Reversible Atrial El — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between atrial fibrillation and immunomodulators	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	Descriptive analysis of the atrial fibrillation cases with immunomodulators significantly associated with atrial fibrillation in the primary analysis	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
Secondary	Identification of molecular/cellular pathway through mechanism of action of immunomodulators associated with AF in the primary analysis.	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
Secondary	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
Secondary	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