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Interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART)

Authors :
Jordana Kron
Thomas Crawford
Virginia Mihalick
Frank Bogun
Jennifer H. Jordan
Todd Koelling
Huzaefah Syed
Aamer Syed
Thomas Iden
Kelly Polly
Emily Federmann
Kirsta Bray
Sangeeta Lathkar-Pradhan
Shilpa Jasti
Lynda Rosenfeld
David Birnie
Melissa Smallfield
Le Kang
Alpha Berry Fowler
Amy Ladd
Kenneth Ellenbogen
Benjamin Van Tassell
W. Gregory Hundley
Antonio Abbate
Source :
Journal of Translational Medicine, Vol 19, Iss 1, Pp 1-11 (2021)
Publication Year :
2021
Publisher :
BMC, 2021.

Abstract

Abstract Background Sarcoidosis is an inflammatory disease characterized by the formation of granulomas, which involve the heart in up to 25% of patients. Cardiac sarcoidosis can lead to life threatening arrhythmias and heart failure. While corticosteroids have been used as a treatment for over 50 years, they are associated with hypertension, diabetes, and weight gain, further increasing cardiovascular risk. Interleukin-1 (IL-1) is the prototypical proinflammatory cytokine that works to activate the nuclear transcription factor NF-kB, one of the targets of glucocorticoids. IL-1 also plays an important role also in the pathophysiology of heart disease including atherosclerosis, myocardial infarction, and myocarditis. Methods Building on a network of research collaborators developed in the Cardiac Sarcoidosis Consortium, we will investigate the feasibility and tolerability of treatment of CS with anakinra at two National Institute of Health Clinical and Translational Science Award (CTSA) hubs with expertise in cardiac sarcoidosis. In this pilot study, up to 28 patients with cardiac sarcoidosis will be recruited to compare the administration of an IL-1 blocker, anakinra, 100 mg daily on top of standard of care versus standard of care only for 28 days and followed for 180 days. Utilizing surrogate endpoints of changes in systemic inflammatory biomarkers and cardiac imaging, we aim to determine whether IL-1 blockade with anakinra can combat systemic and cardiac inflammation in patients with cardiac sarcoidosis. Discussion The current trial demonstrates an innovative collaborative approach to clinical trial development in a rare, understudied disease that disproportionately affects females and minorities. Trial Registration The trial was registered prospectively with ClinicalTrials.gov on July 12, 2019, identifier NCT04017936.

Details

Language :
English
ISSN :
14795876
Volume :
19
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Journal of Translational Medicine
Publication Type :
Academic Journal
Accession number :
edsdoj.4c8d9acdec424382b63edf754d992e7d
Document Type :
article
Full Text :
https://doi.org/10.1186/s12967-021-03130-8