Managing therapy for patients with recurrent pericarditis using Anakinra
Serial Cardiac Magnetic Resonance Imaging for Guidance of Therapy Management in Patients Treated With Anakinra Due to Recurrent Pericarditis
This study is testing if using heart scans along with blood tests can help doctors better manage treatment for adults and kids with recurrent pericarditis who are taking Anakinra.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Azienda Ospedaliero, Universitaria Ospedali Riuniti Academic / other |
| Locations | 1 site (Ancona, Marche) |
| Trial ID | NCT06071156 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of serial cardiac magnetic resonance (CMR) imaging in guiding therapy management for patients with recurrent pericarditis who are being treated with Anakinra. It compares the outcomes of using CMR imaging alongside C-reactive protein (CRP) assays versus using CRP assays alone. The study focuses on adult and pediatric patients who are corticosteroid-dependent or unresponsive to other treatments. By assessing the inflammatory status of the pericardium, the study seeks to optimize treatment strategies for this condition.
Who should consider this trial
Good fit: Ideal candidates include adults and pediatric patients with recurrent pericarditis who are being treated with Anakinra and are either corticosteroid-dependent or unresponsive to colchicine or NSAIDs.
Not a fit: Patients with ongoing infections or those who refuse to participate in the trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with recurrent pericarditis, potentially reducing recurrence rates and enhancing patient outcomes.
How similar studies have performed: While the use of Anakinra for recurrent pericarditis has been explored, the combination of CMR imaging for therapy management is a novel approach that has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients treated with anakinra 100 mg/die if ≥ 18 years old, and * Pediatric patients treated with anakinra 2 mg/kg/die if \< 18 years old * Pediatric and adult patients treated with anakinra due to corticosteroid-dependent or not responsive to colchicine or non-steroidal anti-inflammatory drugs (NSAIDs) recurrent pericarditis Exclusion Criteria: * Ongoing infection (proved within serology) * Refuse to participate in the trial
Where this trial is running
Ancona, Marche
- Ccpc — Ancona, Marche, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Bianco, M.D., Ph.D.
- Email: francesco.bianco@ospedaliriuniti.marche.it
- Phone: +390715965517
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.