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

ConditionPericarditis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorASST Fatebenefratelli Sacco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent from patients aged ≥ 18 years before any evaluation is performed.

Written informed consent from parents or legal guardian and assent from minors aged under 18 years before any evaluation is performed.

Recurrent acute pericarditis during the acute phase of the disease. The diagnosis of pericarditis is based on the presence of at least two of the following criteria: typical pericarditic chest pain (acute and pleuritic, worsened by positional changes or breathing), pericardial friction rub, diffuse ST segment elevation or PR depressions not previously reported, and pericardial effusion.

Post-cardiac injury pericarditis (e.g., post-cardiac surgery) that is new or worsening. Recurrence is diagnosed based on the same criteria.

Disqualifiers

Specific etiologies, including tuberculosis, neoplastic or purulent etiologies, post-cardiac injury syndromes, and autoimmune rheumatic diseases.

Subjects under 18 years of age.

Pregnant or lactating women.

History of immunosuppression, including a positive result on HIV screening tests (ELISA and Western blot).

Trial population

Consecutive patients with different phenotypes of pericarditis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • IL1RA Antibody Assay

    Diagnostic test

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

  • suPAR Testing

    Diagnostic test

    -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.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Inflammatory phenotype2 interventions
Group B: Non-inflammatory phenotype2 interventions

Trial outcomes

Primary outcomes

1

Assessment of IL-1RA antibodies across pericarditis phenotypes

* Levels of anti-IL-1RA antibodies in different phenotypes of pericarditis. * Levels of anti-IL-1RA antibodies during acute episodes and intercritical phases.

Time frame
24 months
2

Assessment of suPAR levels across pericarditis phenotypes

* Levels of suPAR in acute and recurrent pericarditis with normal C-reactive protein (CRP). * Levels of suPAR during acute episodes and intercritical phases.

Time frame
24 months

Secondary outcomes

1

Correlation of Time to Recurrence and Disease Activity with Anti-IL-1RA Antibodies in Pericarditis

* Correlate the time to recurrence with the levels of anti-IL-1RA antibodies. * Correlate overall disease activity indices with the levels of anti-IL-1RA antibodies.

Time frame
24 months
2

Correlation of Time to Recurrence and Disease Activity with suPAR Levels in Pericarditis

* Correlate the time to recurrence with the levels of suPAR. * Correlate overall disease activity indices with the levels of suPAR.

Time frame
24 months

Other outcomes

Sponsors and contacts

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ASST Fatebenefratelli Sacco

Lead sponsor

Fatebenefratelli Hospital

Collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator

Ospedale Galeazzi Sant'Ambrogio - IRCCS

Collaborator

Careggi Hospital

Collaborator

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

Collaborator

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

Collaborator

University of Homburg

Collaborator

University Hospital Tuebingen

Collaborator

Source ClinicalTrials.gov
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