Therapy Management in Patients Treated With Anakinra Due to Recurrent Pericarditis

Recurrent Pericarditis Clinical Trial

Official title:

Serial Cardiac Magnetic Resonance Imaging for Guidance of Therapy Management in Patients Treated With Anakinra Due to Recurrent Pericarditis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06071156
• Other study ID #: CCPC- 003/18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: Azienda Ospedaliero, Universitaria Ospedali Riuniti
• Contact: Francesco Bianco, M.D., Ph.D.
• Phone: +390715965517
• Email: francesco.bianco[@]ospedaliriuniti.marche.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the utility of serial cardiac magnetic resonance (CMR) imaging for guidance of therapy management in patients treated with anakinra due to recurrent pericarditis (RP), compared with c-reactive protein (CRP) assay alone.

Description:

Recurrent pericarditis (RP) is a specific pathology of the pericardium included within the pericardial syndromes by the guidelines of the European Society of Cardiology (ESC). The latter defines RP as pericarditis occurring after a symptom-free interval of 4-6 weeks from a documented first episode of acute pericarditis; the recurrences rate may range from 15 to 30%, with a significant increment of 50% in patients treated with corticosteroids or not treated with colchicine. The diagnosis of recurrences follows the same criteria utilized for acute pericarditis, and a viral etiology can often be demonstrated.

The pathogenesis of RP is still debated, but they are self-sustained by an autoinflammatory/ autoimmune amplified response following an exogenous or endogenous trigger. In this context, the cytokine interleukin 1 (IL-1) has been implicated as a key mediator of RP. Anakinra, an IL-1 antagonist, is of particular interest because it limits the self-sustained pathway of RP and may reduce the recurrences. The current 2015 ESC guidelines for the diagnosis and management of pericardial diseases recommend anakinra in cases of proven infection-negative, corticosteroid-dependent RP not responsive to colchicine, but it remains debated the duration of the therapy and when to start its tapering. In this context, cardiac magnetic resonance (CMR) imaging has recently emerged as an interesting imaging biomarker capable of detecting pericardial inflammation, proving pericardial edema and late gadolinium enhancement (LGE), and distinguishing three defined pericardial inflammation phases: acute (edema and LGE), subacute (only LGE) and burned-out (no edema nor LGE).

To overcome the 2015 ESC guidelines limitations, the investigators sought to determine the utility of serial CMR imaging for guidance of therapy management in patients treated with anakinra due to RP, compared with the c-reactive protein (CRP) assay alone, as currently recommended.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 31, 2025
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pericarditis
• Recurrence
• Recurrent Pericarditis

Intervention

Drug:
• Anakinra
Anakinra, an IL-1 antagonist, is particularly interesting because it limits the self-sustained pathway of recurrent pericarditis and may reduce the recurrences

Locations

Country	Name	City	State
Italy	CCPC	Ancona	Marche

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Ospedali Riuniti

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Adler Y, Charron P, Imazio M, Badano L, Baron-Esquivias G, Bogaert J, Brucato A, Gueret P, Klingel K, Lionis C, Maisch B, Mayosi B, Pavie A, Ristic AD, Sabate Tenas M, Seferovic P, Swedberg K, Tomkowski W; ESC Scientific Document Group. 2015 ESC Guideline — View Citation

Conte E, Agalbato C, Melotti E, Marchetti D, Schillaci M, Ratti A, Ippolito S, Pancrazi M, Perone F, Dalla Cia A, Pepi M, Pontone G, Imazio M, Brucato A, Chetrit M, Klein A, Andreini D. The Contemporary Role of Cardiac Computed Tomography and Cardiac Magn — View Citation

Cremer PC, Lin D, Luis SA, Petersen J, Abbate A, Jellis CL, et al. Pericardial Late Gadolinium Enhancement and Time to Recurrence: A Substudy from RHAPSODY, a Phase 3 Clinical Trial of Rilonacept in Recurrent Pericarditis. European Heart Journal - Imaging

Imazio M, Andreis A, De Ferrari GM, Cremer PC, Mardigyan V, Maestroni S, Luis SA, Lopalco G, Emmi G, Lotan D, Marcolongo R, Lazaros G, De Biasio M, Cantarini L, Dagna L, Cercek AC, Pivetta E, Varma B, Berkson L, Tombetti E, Iannone F, Prisco D, Caforio AL — View Citation

Kumar A, Sato K, Verma BR, Ala CK, Betancor J, Yzeiraj E, Lin L, Mohananey D, Qamruddin S, Kontzias A, Bolen MA, Imazio MM, Kwon DH, Hachamovitch R, Klein AL. Quantitative assessment of pericardial delayed hyperenhancement helps identify patients with ong — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrences of pericarditis	Recurrences of pericarditis during Anakinra reduction regimen of therapy	6 month