This clinical trial is focused on studying a heart condition called virus-negative myocarditis. This condition involves inflammation of the heart muscle that is not caused by a virus. The study is testing a treatment that includes a medication called anakinra, which is an IL-1 inhibitor, meaning it helps reduce inflammation by blocking a specific protein in the body. The treatment will be given in addition to the standard care, which includes medications like azathioprine and prednisone, commonly used to suppress the immune system and reduce inflammation.
The purpose of the study is to evaluate the benefit of adding anakinra to the standard treatment for virus-negative myocarditis. Participants in the study will receive either anakinra or a placebo, along with the standard care. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving anakinra and who is receiving the placebo. This helps ensure that the results are not biased. The treatment will be administered through subcutaneous use, which means it is injected under the skin.
The study will last for a period of six months, during which the participants’ heart function will be monitored. This will be done using a test called Trans Thoracic Echocardiography (TTE), which is a type of ultrasound that looks at how well the heart is pumping. The main goal is to see if the treatment can improve the heart’s ability to pump blood, measured by something called the Left Ventricular Ejection Fraction (LVEF). The study aims to provide valuable information on whether anakinra can be a beneficial addition to the treatment of virus-negative myocarditis.
Italy 
