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

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 y...

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Autores principales:	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
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Cardiac sarcoidosis Interleukin-1 Inflammation Heart failure Medicine R
Acceso en línea:	https://doaj.org/article/4c8d9acdec424382b63edf754d992e7d
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spelling	oai:doaj.org-article:4c8d9acdec424382b63edf754d992e7d2021-11-14T12:08:22ZInterleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART)10.1186/s12967-021-03130-81479-5876https://doaj.org/article/4c8d9acdec424382b63edf754d992e7d2021-11-01T00:00:00Zhttps://doi.org/10.1186/s12967-021-03130-8https://doaj.org/toc/1479-5876Abstract 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.Jordana KronThomas CrawfordVirginia MihalickFrank BogunJennifer H. JordanTodd KoellingHuzaefah SyedAamer SyedThomas IdenKelly PollyEmily FedermannKirsta BraySangeeta Lathkar-PradhanShilpa JastiLynda RosenfeldDavid BirnieMelissa SmallfieldLe KangAlpha Berry FowlerAmy LaddKenneth EllenbogenBenjamin Van TassellW. Gregory HundleyAntonio AbbateBMCarticleCardiac sarcoidosisInterleukin-1InflammationHeart failureMedicineRENJournal of Translational Medicine, Vol 19, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Cardiac sarcoidosis Interleukin-1 Inflammation Heart failure Medicine R
spellingShingle	Cardiac sarcoidosis Interleukin-1 Inflammation Heart failure Medicine R 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 Interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART)
description	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.
format	article
author	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
author_facet	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
author_sort	Jordana Kron
title	Interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART)
title_short	Interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART)
title_full	Interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART)
title_fullStr	Interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART)
title_full_unstemmed	Interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART)
title_sort	interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: anakinra randomized trial (magic-art)
publisher	BMC
publishDate	2021
url	https://doaj.org/article/4c8d9acdec424382b63edf754d992e7d
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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)

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