Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis (MAGiC-ART)
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|ClinicalTrials.gov Identifier: NCT04017936|
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : October 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Sarcoidosis||Drug: Anakinra Drug: Placebos||Phase 2|
Researchers will perform a double-blind randomized placebo-controlled clinical trial of anakinra (recombinant IL-1 receptor antagonist, Kineret, SOBI, Sweden) given for 4 weeks in 28 patients with cardiac sarcoidosis (defined using Heart Rhythm Society diagnostic criteria).
Specific Aim #1: To determine the effects of anakinra on systemic inflammation
Specific Aim #2: To determine the effects of anakinra on cardiac inflammation and fibrosis (scar tissue)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, randomized, placebo-controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||May 2023|
100 mg/0.67 mL daily subcutaneous injection for 4 weeks
Placebo Comparator: Placebo
0.67 mL daily subcutaneous injection for 4 weeks
- Change in inflammation marker [ Time Frame: Baseline to 28 days ]Change in c-reactive protein in participant plasma samples
- Change in cardiac functioning [ Time Frame: Baseline to 28 ]Change in heart function as measured by tracer activity using positron emission tomography (PET) scans
- Change in cardiac damage [ Time Frame: Baseline to 28 ]Change in late gadolinium enhancement evident on magnetic resonance imaging (MRI) scan
- Number of serious cardiac events [ Time Frame: 28 days ]Sum of hospitalizations and deaths due to cardiac causes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017936
|Contact: Jordana Kron, MDemail@example.com|
|Contact: Antonio Abbate, ME, PhDfirstname.lastname@example.org|
|United States, Virginia|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Jennifer Jordan, PhD 804-628-6239 Jennifer.Jordan@vcuhealth.org|
|Principal Investigator:||Jordana Kron, MD||Virginia Commonwealth University|