Anakinra Versus Placebo for the Treatment of Acute MyocarditIS

Summary

There is no specific treatment of acute myocarditis, especially during the inflammatory period. Interleukin (IL) is specifically involved during this period and play a role in myocardial oedema. ANAKINRA, an IL-1β Blocker, is a new treatment that has never been evaluated in myocarditis. The benefit for the patient could be important with a reduction of heart failure and ventricular arrhythmias. Hypothesis : ANAKINRA in addition to standard therapy for treatment of Acute Myocarditis is superior to standard therapy based on an association of beta-blockers and Angiotensin-Converting-Enzyme inhibitor (ACE).

Timeline

Start

2017-05-30

Primary completion

2021-06-28

Completion

2022-05-30

Publications

• Werner B, Roznowska-Wojtowicz A, Puchalski M. Diagnosis and Management of Pediatric Myocarditis. Pediatr Infect Dis J. 2025 Mar 1;44(3):e95-e98. doi: 10.1097/INF.0000000000004678. Epub 2024 Dec 17. No abstract available.
• Kerneis M, Cohen F, Combes A, Amoura Z, Pare C, Brugier D, Puymirat E, Abtan J, Lattuca B, Dillinger JG, Hauguel-Moreau M, Silvain J, Salem JE, Gandjbakhch E, Hekimian G, Redheuil A, Vicaut E, Montalescot G; ACTION Study Group. Rationale and design of the ARAMIS trial: Anakinra versus placebo, a double blind randomized controlled trial for the treatment of acute myocarditis. Arch Cardiovasc Dis. 2023 Oct;116(10):460-466. doi: 10.1016/j.acvd.2023.07.004. Epub 2023 Aug 12.

Drugs

Indications