Atrial FibrillationNCT06095791
Identification of Immunomodulators Associated With Atrial Fibrillation Reporting: Analysis of the WHO Pharmacovigilance Database
An observational study of Atrial Fibrillation, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Immunomodulators with FDA approval on the 1st January 2023.
- How many people
- 4,000,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Immunomodulators with FDA approval on the 1st January 2023.
- Keywords
- Immunomodulators, Pharmacovigilance, Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Aug 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095791
- Sponsor's protocol ID
- CaenUH_JF_1
- Status last verified
- Aug 2022
- First submitted
- 8 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32353110Lazzerini 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.
PubMed 27252448Guo 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.
PubMed 23194937Lazzerini 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.
PubMed 31423933Font J, Dolladille C, Divoux J, Chretien B, de Boysson H, Legallois D, Ollitrault P, Champ-Rigot L, Ferchaud V, Pellissier A, Milliez P, Alexandre J. Identification of immunomodulators associated with atrial fibrillation reporting to better understand AF immunologic mechanisms: a Vigibase retrospective disproportionality analysis and a literature review. BMJ Open. 2026 Apr 7;16(4):e098166. doi: 10.1136/bmjopen-2024-098166.
PubMed 41946548
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Immunomodulators Associated With Atrial Fibrillation Reporting: Analysis of the WHO Pharmacovigilance Database
- ClinicalTrials.gov ID
- NCT06095791
- Acronym / sponsor ID
- CaenUH_JF_1
- Conditions
- Atrial Fibrillation
- Keywords
- Immunomodulators, Pharmacovigilance, Atrial fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000,000 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | – |
Primary outcome
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).
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Results publication: PubMed 32353110Alexandre 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.
- Results publication: PubMed 27252448Lazzerini 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.
- Results publication: PubMed 23194937Guo 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.
- Results publication: PubMed 31423933Lazzerini 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.
- Derived from this study: PubMed 41946548Font J, Dolladille C, Divoux J, Chretien B, de Boysson H, Legallois D, Ollitrault P, Champ-Rigot L, Ferchaud V, Pellissier A, Milliez P, Alexandre J. Identification of immunomodulators associated with atrial fibrillation reporting to better understand AF immunologic mechanisms: a Vigibase retrospective disproportionality analysis and a literature review. BMJ Open. 2026 Apr 7;16(4):e098166. doi: 10.1136/bmjopen-2024-098166.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between atrial fibrillation and immunomodulators (time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06095791, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.