Actively Recruiting

Age: 18Years - 90Years
All Genders
ID05925790

Observational Study on Anti-interleukin-1 Receptor Antagonist Antibodies and suPAR Levels in Pericarditis to Understand Disease Phenotypes

Led by ASST Fatebenefratelli Sacco · Updated on 2024-07-03

146

Participants Needed

9

Research Sites

24 weeks

Total Duration

On this page

Sponsors

A

ASST Fatebenefratelli Sacco

Lead Sponsor

F

Fatebenefratelli Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating recurrent pericarditis (RP), a condition that affects the heart's lining and can cause repeated episodes of inflammation. This study aims to explore the underlying causes of RP by testing for specific antibodies against the interleukin-1 receptor antagonist (IL-1RA) and measuring levels of soluble urokinase plasminogen activator receptor (suPAR). These tests may help distinguish between inflammatory and non-inflammatory forms of RP and improve understanding of how the disease works. The study also examines the relationship between these markers and signs of heart damage and inflammation, with the goal of guiding treatment decisions involving anakinra, a medication that blocks IL-1 pathways. Participants will be assessed based on whether they show signs of inflammation during RP episodes, such as fever or elevated blood markers, or if they have a non-inflammatory form without these signs. The study uses blood tests to measure IL-1RA antibodies and suPAR levels through established laboratory methods. Testing will occur during acute flare-ups and periods between episodes when possible, to track changes over time. Patients continue their usual care without changes influenced by the study. Throughout the study, participants will provide blood samples and undergo clinical evaluations to measure markers of inflammation and heart health. Researchers will track how antibody and suPAR levels relate to disease activity and recurrence over 24 months. The study is observational, focusing on collecting detailed biological and clinical data to better characterize RP subtypes and improve future treatment approaches. Safety and ongoing medical care are maintained throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent from patients aged 18 years or older before any evaluation is performed.
  • Recurrent acute pericarditis diagnosed by at least two specific clinical criteria during the acute phase.
  • Post-cardiac injury pericarditis that is new or worsening, diagnosed by the same criteria.
  • Known history of CRP values to distinguish inflammatory from non-inflammatory forms.
  • Acute phase defined by CRP at least twice the normal value or clinical judgment for normal CRP cases.
Not Eligible

You will not qualify if you...

  • Pericarditis due to tuberculosis, neoplastic or purulent causes, post-cardiac injury syndromes, or autoimmune rheumatic diseases.
  • Individuals under 18 years of age.
  • Pregnant or lactating women.
  • History of immunosuppression including positive HIV tests.
  • Positive tuberculosis screening tests (QuantiFERON or PPD).
  • Other significant medical conditions that may affect study results.
  • Use of medications that may alter test results except those for pericarditis treatment.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 24 months

Participants undergo blood tests to measure IL-1RA antibodies and suPAR levels to help understand different pericarditis phenotypes.

Longitudinal blood sampling during acute episodes and intercritical phases when feasible

Long-term Monitoring

Duration - 24 months

Participants are monitored over time to assess correlations between antibody and suPAR levels with disease activity and recurrence.

Periodic evaluations depending on clinical course

Trial Site Locations

Total: 9 locations

1

Saarland University

Homburg, Germany

Actively Recruiting

2

University Children's Hospital Muenster

Münster, Germany

Not Yet Recruiting

3

University Hospital Tübingen

Tübingen, Germany

Not Yet Recruiting

4

A.O.U. Careggi

Florence, Italy

Not Yet Recruiting

5

Luigi Sacco Hospital - ASST Fatebenefratelli Sacco

Milan, Italy, 20157

Actively Recruiting

6

Fatebenefratelli Hospital - ASST Fatebenefratelli Sacco

Milan, Italy

Actively Recruiting

7

Ospedale Galeazzi Sant'Ambrogio - IRCCS, Poliambulatorio Cardiovascolare Cardiologia Universitaria

Milan, Italy

Not Yet Recruiting

8

Policlinico di Milano Ospedale Maggiore, Fondazione IRCCS Ca' Granda

Milan, Italy

Not Yet Recruiting

9

Ospedale Santa Maria della Misericordia dell'ASU-FC

Udine, Italy

Not Yet Recruiting

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Research Team

M

Maddalena A Wu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

The autoinflammatory side of recurrent pericarditis: Enlightening the pathogenesis for a more rational treatment.

Giuseppe Lopalco, Donato Rigante, Luca Cantarini...

https://pubmed.ncbi.nlm.nih.gov/32376492

2015 ESC Guidelines for the diagnosis and management of pericardial diseases: The Task Force for the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology (ESC)Endorsed by: The European Association for Cardio-Thoracic Surgery (EACTS).

Yehuda Adler, Philippe Charron, Massimo Imazio...

https://pubmed.ncbi.nlm.nih.gov/26320112

Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence: The AIRTRIP Randomized Clinical Trial.

Antonio Brucato, Massimo Imazio, Marco Gattorno...

https://pubmed.ncbi.nlm.nih.gov/27825009

Anakinra for corticosteroid-dependent and colchicine-resistant pericarditis: The IRAP (International Registry of Anakinra for Pericarditis) study.

Massimo Imazio, Alessandro Andreis, Gaetano Maria De Ferrari...

https://pubmed.ncbi.nlm.nih.gov/31610707

Soluble Urokinase Plasminogen Activator Receptor (suPAR) as a Biomarker of Systemic Chronic Inflammation.

Line Jee Hartmann Rasmussen, Jens Emil Vang Petersen, Jesper Eugen-Olsen

https://pubmed.ncbi.nlm.nih.gov/34925360