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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Saarland University
RECRUITING
Homburg
University Children's Hospital Muenster
NOT_YET_RECRUITING
Münster
University Hospital Tübingen
NOT_YET_RECRUITING
Tübingen
Italy
A.O.U. Careggi
NOT_YET_RECRUITING
Florence
Fatebenefratelli Hospital - ASST Fatebenefratelli Sacco
RECRUITING
Milan
Luigi Sacco Hospital - ASST Fatebenefratelli Sacco
RECRUITING
Milan
Ospedale Galeazzi Sant'Ambrogio - IRCCS, Poliambulatorio Cardiovascolare Cardiologia Universitaria
NOT_YET_RECRUITING
Milan
Policlinico di Milano Ospedale Maggiore, Fondazione IRCCS Ca' Granda
NOT_YET_RECRUITING
Milan
Ospedale Santa Maria della Misericordia dell'ASU-FC
NOT_YET_RECRUITING
Udine
Contact Information
Primary
Maddalena A Wu
maddalena.wu@unimi.it
+393392883379
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2025-12-20
Participants
Target number of participants: 146
Treatments
Inflammatory phenotype
Patients with the inflammatory phenotype of recurrent pericarditis exhibit signs indicating the presence of an inflammatory process during a recurrence. These signs may include one or more of the following:~* Fever~* Elevated C-reactive protein (CRP)~* Elevated white blood cell (WBC) count~* Elevated erythrocyte sedimentation rate (ESR)~* Pericardial late gadolinium enhancement (LGE) on cardiac magnetic resonance imaging (CMR)~* Pericardial contrast enhancement on computed tomography (CT)
Non-inflammatory phenotype
Patients with the non-inflammatory phenotype of recurrent pericarditis do not exhibit any of the signs typically associated with an active inflammatory process during a recurrence. These patients present without:~* Fever~* Elevated CRP~* Elevated WBC count~* Elevated ESR~* Pericardial LGE on CMR~* Pericardial contrast enhancement on CT
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Tuebingen, Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy, University of Homburg, Careggi Hospital, Ospedale Galeazzi Sant'Ambrogio - IRCCS, Children's Medical Hospital, University of Muenster, Muenster, Germany, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Fatebenefratelli Hospital
Leads: ASST Fatebenefratelli Sacco

This content was sourced from clinicaltrials.gov