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

NCT06095791 | Completed FDA Drug

• 1 other identifier: CaenUH_JF_1
• Study Type: observational
• Target: 4,000,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Immunomodulators; Pharmacovigilance; Atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

Interventions

Immunomodulators with FDA approval on the 1st January 2023. DRUG

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Alexandre Joachim

Caen, Basse Normandie, 14000, France

Location

Related 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 fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037.

  PMID: 32353110 RESULT

• 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.

  PMID: 27252448 RESULT

• 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.

  PMID: 23194937 RESULT

• 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 Electrical Remodeling: The Role of Interleukin-6-Mediated Changes in Connexin Expression. J Am Heart Assoc. 2019 Aug 20;8(16):e011006. doi: 10.1161/JAHA.118.011006. Epub 2019 Aug 19.

  PMID: 31423933 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Immunologic Factors

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 23, 2023
• Study Start: August 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 23, 2023

Record last verified: 2022-08

Locations

FR (1)