Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Sarcoidosis is a heterogeneous disorder of unknown etiology whose signature lesions are
granulomatous inflammatory infiltrates in involved tissues. Tissue commonly affected are
lungs, skin, eyes, lymph nodes and the heart. In this latter case, cardiac sarcoidosis (CS)
can lead to atrioventricular (AV) blocks, ventricular arrhythmias, heart failure (HF) and
sudden cardiac death. Similar to other involved organs, cardiac disease generally progresses
from areas of focal inflammation to scar. However, the natural history of CS is not well
characterized complicating an immediate and definitive diagnosis. The management of CS often
requires multidisciplinary care teams and is challenged by data limited to small
observational studies and from the high likelihood of side effects of most of the treatments
currently used (eg: corticosteroids, methotrexate and TNF-alfa inhibitors).
Interleukin-1 (IL-1) is the prototypical pro-inflammatory cytokine, also referred to as
master regulator of the inflammatory response, involved in virtually every acute process.
There is evidence that IL-1 plays a role in mouse model of sarcoidosis and human pulmonary
lesions as the presence of the inflammasome in granulomas of the heart of patients with
cardiac sarcoidosis, providing additional support for a role of IL-1 in the pathogenesis of
CS. However, IL-1 blockade has never been evaluated as a potential therapeutic agent for
cardiac sarcoidosis.
In the current study, researchers aim to evaluate the safety and efficacy of IL-1 blockade
with anakinra (IL-1 receptor antagonist) in patients with cardiac sarcoidosis.
Phase:
Phase 2
Details
Lead Sponsor:
Virginia Commonwealth University
Collaborators:
American Heart Association National Center for Advancing Translational Science (NCATS)