image dons

I make a donation

Rationale and design of the ARAMIS trial: Anakinra versus placebo, a double blind randomized controlled trial for the treatment of acute myocarditis

La Grande Journée du Coeur (13 juin 2023)
Les vidéos sont en ligne !

La Grande Journée du Coeur (mardi 13 juin 2023)
Les présentations sont en ligne

Archives of Cardiovascular Diseases 2023 Oct;116(10):460-466
Article disponible en consultant le site


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.



Acute myocarditis is an inflammation of the myocardium that can cause life-threatening events. However, anti-inflammatory strategies did not reduce the risk of clinical outcomes in randomized trials. Recently, experimental studies have suggested that specific blockade of the interleukin-1β immune innate pathway could be effective in acute myocarditis.


To test the hypothesis that inhibition of the interleukin-1β immune innate pathway can reduce the risk of clinical events in acute myocarditis.


The “Anakinra versus placebo double blind Randomized controlled trial for the treatment of Acute MyocarditIS” (ARAMIS) trial ( identifier: NCT03018834) is a national multicentre randomized parallel-group double blind study among symptomatic patients with elevated cardiac troponin and cardiac magnetic resonance-proven acute myocarditis. Patients (n = 120) are randomized within 72 hours of hospital admission to receive a daily subcutaneous dose of anakinra 100 mg or placebo during the hospitalization, in addition to standard of care, including an angiotensin-converting enzyme inhibitor and a beta-blocker. The primary endpoint is the number of days alive free from any myocarditis complication, including ventricular arrhythmias, heart failure, recurrent chest pain requiring medication and ventricular dysfunction (defined as left ventricular ejection fraction < 50%), from randomization to 28 days after hospital discharge. At 28 days after discharge, patients with normal left ventricular ejection fraction are then randomized to angiotensin-converting enzyme inhibitor continuation or discontinuation and all patients are followed for 1 year, with regular left ventricular function evaluation.


ARAMIS is the first trial evaluating inhibition of the interleukin-1β immune innate pathway in the setting of acute myocarditis. Although of small size, it will be the largest randomized trial in acute myocarditis, a serious and poorly studied cardiac condition.

Autres actualités



Comparison of three echo-guidance techniques in percutaneous...

Arch Cardiovasc Dis. 2023 Sep 29:S1875-2136(23)00171-7