Pericarditis Clinical Trial
— PERIPLOOfficial 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
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.
Status | Not yet recruiting |
Enrollment | 146 |
Est. completion date | December 20, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - 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. In all patients, the previous history of CRP values should be known to distinguish individuals with inflammatory forms (characterized by significantly elevated CRP values in the clinical history) from those with pericarditis and normal or near-normal CRP levels (clinical history of normal or at most less than 2 times the normal value). The acute phase of the disease is defined as follows: for pericarditis forms with elevated CRP, the presence of a CRP that is at least double the normal value of the test. For forms with normal CRP, it is based on clinical judgment, as there are no other recognized and validated criteria. Exclusion Criteria: - 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). - Positive QuantiFERON test (QFT-Tuberculosis G In-Tube) or positive Purified Protein Derivative (PPD) test after the initial clinical evaluation. - History of other significant medical conditions that, according to the investigator, could compromise the outcome or interpretation of the results (e.g., systemic diseases that are not directly the cause of pericarditis but may cause a state of chronic inflammation). - Use of any medication that the investigator believes could alter the result of the tests to be performed (except those used for the treatment of pericarditis). Throughout the study, patients will continue to receive the most appropriate therapies for their clinical condition, following current guidelines and good clinical practice, without the participation in the study prejudicing or influencing the choice of therapeutic strategies to be employed. |
Country | Name | City | State |
---|---|---|---|
Germany | Saarland University | Homburg | |
Germany | University Children's Hospital Muenster | Muenster | |
Germany | University Hospital Tübingen | Tübingen | |
Italy | A.O.U. Careggi | Florence | |
Italy | Fatebenefratelli Hospital - ASST Fatebenefratelli Sacco | Milan | |
Italy | Luigi Sacco 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 |
Lead Sponsor | Collaborator |
---|---|
ASST Fatebenefratelli Sacco | Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy, Careggi Hospital, Children's Medical Hospital, University of Muenster, Muenster, Germany, Fatebenefratelli Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ospedale Galeazzi Sant'Ambrogio - IRCCS, University Hospital Tuebingen, University of Homburg |
Germany, Italy,
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Chiabrando JG, Bonaventura A, Vecchie A, Wohlford GF, Mauro AG, Jordan JH, Grizzard JD, Montecucco F, Berrocal DH, Brucato A, Imazio M, Abbate A. Management of Acute and Recurrent Pericarditis: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jan 7;75(1):76-92. doi: 10.1016/j.jacc.2019.11.021. — View Citation
Hodges GW, Bang CN, Wachtell K, Eugen-Olsen J, Jeppesen JL. suPAR: A New Biomarker for Cardiovascular Disease? Can J Cardiol. 2015 Oct;31(10):1293-302. doi: 10.1016/j.cjca.2015.03.023. Epub 2015 Mar 25. — View Citation
Imazio M, Andreis A, De Ferrari GM, Cremer PC, Mardigyan V, Maestroni S, Luis SA, Lopalco G, Emmi G, Lotan D, Marcolongo R, Lazaros G, De Biasio M, Cantarini L, Dagna L, Cercek AC, Pivetta E, Varma B, Berkson L, Tombetti E, Iannone F, Prisco D, Caforio ALP, Vassilopoulos D, Tousoulis D, De Luca G, Giustetto C, Rinaldi M, Oh JK, Klein AL, Brucato A, Adler Y. Anakinra for corticosteroid-dependent and colchicine-resistant pericarditis: The IRAP (International Registry of Anakinra for Pericarditis) study. Eur J Prev Cardiol. 2020 Jun;27(9):956-964. doi: 10.1177/2047487319879534. Epub 2019 Oct 15. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
24 months | |
Primary | 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. |
24 months | |
Secondary | 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. |
24 months | |
Secondary | 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. |
24 months |
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