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
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 design
Treatments tested in this trial
- IL1RA Antibody Assay
- suPAR Testing
Treatment groups
146 Participants
are divided into 2 treatment groupsSponsors and collaborators
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