Anakinra Versus Placebo for the Treatment of Acute MyocarditIS

Sponsored by Assistance Publique - Hôpitaux de Paris

About this trial

Last updated 2 years ago

Study ID

P150921

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18 to 64 Years

All Sexes

Trial Timing

Ended 4 years ago

What is this trial about?

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).

What are the participation requirements?

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