Coronary artery stenosis > 50% at angiography or coronary CT Scan (acceptable if performed during the last 12 months).

Evidence of genome of cardiotropic viruses by Polymerase chain reaction on EBM.

Clinical suspicion or proven underlying disease: Lyme disease, any other bacterial disease possibly responsible for myocarditis, trypanosomiase disease, giant cell myocarditis.

Known presence or suspicion of active or recurrent bacterial, fungal or viral infections, including tuberculosis, or HIV infection or hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Pregnancy, breastfeeding. Female patients of childbearing potential may participate if adequate contraception is used during the study. (For the purposes of this trial, women of childbearing potential are defined as “All female subjects after puberty unless they are post-menopausal for at least 2 years or are surgically sterile.”

Contra-indication to ANAKINRA (known hypersensitivity to the active substance or to any of the excipients or to Escherichia coli-derived proteins).

Presence of neutropenia < 1,5.109/L).

Renal failure as defined by estimated glomerular filtration rate (eGFR) <30 ml/min, according to Cockcroft-Gault.

Any comorbidity limiting survival or conditions predicting inability to complete the study.

History of malignancy in the previous 5 years. Exceptions are basal cell skin cancer, carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy.

Any other previous biological treatment administered within 5 -half lives of the specific drug.

Any concomitant immune-suppressive medications other than those included in the study protocol.

Therapy with prednisone >10 mg daily and/or immuno-suppressive agents within 3 months before the enrolment.

Hepatic impairment = Child-Pugh Class C

Mechanical ventilation circulatory assistance.

Myocarditis Therapy with IL-1 inhibitor (MYTH-1): a double-blind, phase IIa, placebo-controlled, randomized clinical trial to evaluate the efficacy and safety of anakinra in addition to standard of care for the treatment of virus-negative myocarditis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations