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RECRUITING
NCT05925790

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

Sponsor: ASST Fatebenefratelli Sacco

View on ClinicalTrials.gov

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.

Official title: Observational Study on Anti-interleukin-1 Receptor Antagonist Antibodies and Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Pericarditis: PERIPLO (PERicarditis: IL-1 RA Antibodies and suPAR Levels Observational) Study

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

146

Start Date

2023-07-01

Completion Date

2025-12-20

Last Updated

2024-07-03

Healthy Volunteers

No

Conditions

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.

Locations (9)

Saarland University

Homburg, Germany

University Children's Hospital Muenster

Münster, Germany

University Hospital Tübingen

Tübingen, Germany

A.O.U. Careggi

Florence, Italy

Luigi Sacco Hospital - ASST Fatebenefratelli Sacco

Milan, Italy

Fatebenefratelli Hospital - ASST Fatebenefratelli Sacco

Milan, Italy

Ospedale Galeazzi Sant'Ambrogio - IRCCS, Poliambulatorio Cardiovascolare Cardiologia Universitaria

Milan, Italy

Policlinico di Milano Ospedale Maggiore, Fondazione IRCCS Ca' Granda

Milan, Italy

Ospedale Santa Maria della Misericordia dell'ASU-FC

Udine, Italy