Clinical Phenotypes in Pericarditis: IL-1RA Antibodies and suPAR Levels

Summary

This study aims to investigate the pathophysiology of recurrent pericarditis (RP) by testing for neutralizing autoantibodies against interleukin-1 receptor antagonist (IL-1RA) and measuring soluble urokinase plasminogen activator receptor (suPAR) levels. The hypothesis is that these tests will provide insights into both the inflammatory and non-inflammatory phenotypes of RP, shedding light on the underlying mechanisms. The study will assess the correlation between antibody levels, suPAR levels, and markers of cardiac damage and inflammation. Longitudinal testing during acute episodes and intercritical phases is also planned. The results may guide the use of anakinra, an IL-1 receptor antagonist, in specific clinical scenarios and optimize treatment strategies for RP.

Conditions

• Pericarditis

Interventions

DIAGNOSTIC_TEST

IL1RA Antibody Assay

-The measurement of anti-interleukin-1 receptor antagonist (IL1RA) antibodies will be performed using the ELISA (Enzyme-Linked Immunosorbent Assay) method,as previously described \[Thurner, L., et al., IL-1RA Antibodies in Myocarditis after SARS-CoV-2 Vaccination. N Engl J Med, 2022. 387(16): p. 1524-1527\].

DIAGNOSTIC_TEST

suPAR Testing

-The quantitative determination of soluble urokinase plasminogen activator receptor (suPAR) levels in blood will be conducted using the commercially available "CHORUS suPAR Extended" kit (cod. 81414, DIESSE Diagnostica Senese S.p.A., Siena, Italy), based on the principle of the sandwich ELISA method.

Sponsors & Collaborators

• Fatebenefratelli Hospital

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Ospedale Galeazzi Sant'Ambrogio - IRCCS

  collaborator UNKNOWN

• Careggi Hospital

  collaborator OTHER

• Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy

  collaborator OTHER

• Children's Medical Hospital, University of Muenster, Muenster, Germany

  collaborator OTHER

• University of Homburg

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• ASST Fatebenefratelli Sacco

  lead OTHER

Principal Investigators

• Maddalena A Wu · ASST Fatebenefratelli Sacco

• Antonio L Brucato · Fatebenefratelli Hospital

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-01

Primary Completion

2025-07-01

Completion

2025-12-20

Countries

• Germany
• Italy

Study Locations