Investigating the role of IL-1RA antibodies and suPAR levels in recurrent pericarditis

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 is trying to see if certain antibodies and protein levels in the blood can help us understand and improve treatment for people with recurrent pericarditis.

Quick facts

• Study type: Observational
• Enrollment: 146 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: ASST Fatebenefratelli Sacco (Academic / other)
• Locations: 9 sites (Homburg and 8 other locations)
• Trial ID: NCT05925790 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the pathophysiology of recurrent pericarditis by testing for neutralizing autoantibodies against interleukin-1 receptor antagonist (IL-1RA) and measuring soluble urokinase plasminogen activator receptor (suPAR) levels. The research will assess the correlation between these antibody levels, suPAR levels, and markers of cardiac damage and inflammation during acute episodes and intercritical phases. By understanding the inflammatory and non-inflammatory phenotypes of recurrent pericarditis, the study seeks to optimize treatment strategies, potentially guiding the use of anakinra in specific clinical scenarios.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with recurrent acute pericarditis or post-cardiac injury pericarditis.

Not a fit: Patients with non-recurrent forms of pericarditis or those without elevated CRP values may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with recurrent pericarditis, enhancing their quality of life and reducing healthcare resource utilization.

How similar studies have performed: While the approach of investigating IL-1RA antibodies in pericarditis is relatively novel, similar studies in other inflammatory conditions have shown promising results.

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.

Where this trial is running

Homburg and 8 other locations

• Saarland University — Homburg, Germany (Recruiting)
• University Children's Hospital Muenster — Münster, Germany (Not_yet_recruiting)
• University Hospital Tübingen — Tübingen, Germany (Not_yet_recruiting)
• A.O.U. Careggi — Florence, Italy (Not_yet_recruiting)
• Luigi Sacco Hospital - ASST Fatebenefratelli Sacco — Milan, Italy (Recruiting)
• Fatebenefratelli Hospital - ASST Fatebenefratelli Sacco — Milan, Italy (Recruiting)
• Ospedale Galeazzi Sant'Ambrogio - IRCCS, Poliambulatorio Cardiovascolare Cardiologia Universitaria — Milan, Italy (Not_yet_recruiting)
• Policlinico di Milano Ospedale Maggiore, Fondazione IRCCS Ca' Granda — Milan, Italy (Not_yet_recruiting)
• Ospedale Santa Maria della Misericordia dell'ASU-FC — Udine, Italy (Not_yet_recruiting)

Study contacts

• Principal investigator: Maddalena A Wu — ASST Fatebenefratelli Sacco
• Study coordinator: Maddalena A Wu

Conditions Pericarditis; Anti-interleukin-1 receptor antagonist antibodies; Soluble urokinase plasminogen activator receptor; Pericarditis phenotypes