2024-515472-13-00RecruitingPhase 2
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.
Ospedale San Raffaele S.r.l., Ospedale San Raffaele S.r.l.1 site in 1 country32 target enrollmentStarted: October 16, 2024Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- To evaluate the benefit of Anakinra combined with standard immunosuppressive therapy in improving Left Ventricular Ejection Fraction (LVEF) assessed by Trans Thoracic Echocardiograhy (TTE) at 2 months.
Study Overview
Brief Summary
To evaluate the benefit of Anakinra combined with standard immunosuppressive therapy with azathioprine and prednisone in the treatment of virus-negative myocarditis.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 Years to 75 Years
- •Myocarditis defined by cardiac magnetic resonance (according with Lake Louise Criteria) and virus-negativity defined by on endomyocardial biopsy.
- •Any impairment of left ventricular ejection fraction (LV-EF) <55% on Trans Thoracic Echocardiography.
- •Ability to sign an informed consent.
Exclusion Criteria
- •Coronary artery stenosis > 50% at angiography or coronary CT Scan (acceptable if performed during the last 12 months).
- •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.
- •Congenital and/or acquired valvular disease or any other heart disease that could justify the severity of cardiac dysfunction.
- •Major surgery within 2 weeks prior to randomization, or unhealed operation wounds.
- •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.
Outcomes
Primary Outcomes
To evaluate the benefit of Anakinra combined with standard immunosuppressive therapy in improving Left Ventricular Ejection Fraction (LVEF) assessed by Trans Thoracic Echocardiograhy (TTE) at 2 months.
To evaluate the benefit of Anakinra combined with standard immunosuppressive therapy in improving Left Ventricular Ejection Fraction (LVEF) assessed by Trans Thoracic Echocardiograhy (TTE) at 2 months.
Secondary Outcomes
No secondary outcomes reported
Investigators
Giacomo De Luca
Scientific
Ospedale San Raffaele S.r.l.
Study Sites (1)
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