Anakinra Versus Placebo for the Treatment of Acute MyocarditIS

• Status: Active, not recruiting
• Trial end date: 2022-05-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Adrenergic beta-Antagonists; Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Patients hospitalized for Acute myocarditis defined as:

• Chest Pain (or modification of the ECG) AND Troponin Rise (*1.5 Normal range) AND Myocarditis proven by MRI in the first 72h after admission

• Age > 18 and <65 years old

• Accepting effective contraception during treatment duration (men and women childbearing potential)

• Signed informed consent Normal Coronary angiography or coronary CT Scan (made during the previous year is acceptable) (normal is defined as stenosis < 50%) (In the case of patients under 40 with typical MRI of myocarditis, coronary angiography is not mandatory and left to the doctor's discretion)

Exclusion Criteria:

• Active coronary disease

• Clinical Suspicion or proven underlying disease: systemic lupus, antiphospholipid antibodies, Lyme disease, trypanosomiase disease, myositis, signs of sarcoidosis, giant cell myocarditis, treated chronic inflammatory disease, tuberculosis, HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV), Hepatitis B virus (HBV) infection,

• Latex allergy

• Pregnancy, breastfeeding

• Contra-indication to ANAKINRA (known hypersensitivity to the active substance or to any of the excipients, neutropenia < 1,5.10^9/L)

• Renal failure, Creatine Clearance (CrCl) < 30 ml/min (MDRD)

• Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study

• History of malignancy

• Non Steroidian Anti Inflammatory drug within the past 14 days

• Anti Tumor Necrosis Factor (TNF) within the past 14 days

• No affiliation to the French Health Care System "sécurité sociale"

• Hepatic impairment = Child-Pugh Class C

• Mechanical ventilation

• Circulatory assistance