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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515472-13-00

Enrollment

Registered

2024-10-16

Start date

2021-09-23

Completion date

Unknown

Last updated

2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endomyocardial biopsy (EBM)-proven virus-negative myocarditis

Brief summary

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.

Interventions

DRUGANAKINRA

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026