Status:

RECRUITING

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

Lead Sponsor:

ASST Fatebenefratelli Sacco

Collaborating Sponsors:

Fatebenefratelli Hospital

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Conditions:

Pericarditis

Eligibility:

All Genders

18-90 years

Brief 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 ur...

Detailed Description

Recurrent pericarditis (RP) is a complex challenging condition, which significantly impacts patients' quality of life, both from the physical and emotional point of view, and can lead to dangerous com...

Eligibility Criteria

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.

Key Trial Info

Start Date :

July 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 20 2025

Estimated Enrollment :

146 Patients enrolled

Trial Details

Trial ID

NCT05925790

Start Date

July 1 2023

End Date

December 20 2025

Last Update

July 3 2024

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

Saarland University

Homburg, Germany

2

University Children's Hospital Muenster

Münster, Germany

3

University Hospital Tübingen

Tübingen, Germany

4

A.O.U. Careggi

Florence, Italy