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Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis

2019-07-15 10:04:53 | BioPortfolio

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.

Description

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 Design

Conditions

Cardiac Sarcoidosis

Intervention

Anakinra, Placebos

Status

Not yet recruiting

Source

Virginia Commonwealth University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-15T10:04:53-0400

Clinical Trials [1117 Associated Clinical Trials listed on BioPortfolio]

Non-Invasive Characterization in Cardiac Sarcoidosis

In a study of Cardiac sarcoidosis, a serious heart condition, a radiotracer is being used to examine inflammation.

Somatostatin Receptor Imaging in Cardiac Sarcoidosis

The purpose of the trial is to determine the accuracy of Cu-64 labelled DOTATATE for diagnosing cardiac sarcoidosis using PET/CT or PET/MRI.

Implantable Cardiac Defibrillators for the Prevention of Sudden Death in Patients With Cardiac Sarcoidosis

The purpose of this study is to identify patients with cardiac sarcoidosis who may be at risk for sudden death.

Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

The aim of the study is to find better and more specific non-invasive methods to diagnose and stage cardiac sarcoidosis with the use of advanced imaging modalities, simultaneous 3T MRI and...

Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis

The purpose and objectives of the study is to establish the feasibility of the simultaneous PET/MR in patients with cardiac sarcoidosis, determine relationships between various imaging bio...

PubMed Articles [3791 Associated PubMed Articles listed on BioPortfolio]

Serial Cardiac FDG-PET for the Diagnosis and Therapeutic Guidance of Patients with Cardiac Sarcoidosis.

Cardiac fluorodeoxyglucose positron emission tomography (FDG-PET) has emerged as a standard imaging modality for the diagnosis of cardiac sarcoidosis (CS); however, there is a scarcity of data on the ...

Cardiac Sympathectomy For Refractory Ventricular Arrhythmias in Cardiac Sarcoidosis.

Ventricular arrhythmias (VA) in cardiac sarcoidosis (CS) are frequently refractory to both anti-arrhythmic drug therapy (AAD) and catheter ablation (CA). Cardiac sympathetic denervation (CSD) has been...

Sudden death in cardiac sarcoidosis: an analysis of nationwide clinical and cause-of-death registries.

The present study was done to assess the role of sudden cardiac death (SCD) among the presenting manifestations of and fatalities from cardiac sarcoidosis (CS).

The role of positron emission tomography in the assessment of cardiac sarcoidosis.

The myocardium and the cardiovascular system are often involved in patients with sarcoidosis. As therapy should be started as early as possible to avoid complications such as left ventricular dysfunct...

Ichthyosiform sarcoidosis and systemic involvement.

Sarcoidosis is a systemic disease that can be suspected based on cutaneous findings and confirmed using diagnostic testing such as biopsy and laboratory or radiographic studies. We report the case of ...

Medical and Biotech [MESH] Definitions

Sarcoidosis affecting predominantly the lungs, the site most frequently involved and most commonly causing morbidity and mortality in sarcoidosis. Pulmonary sarcoidosis is characterized by sharply circumscribed granulomas in the alveolar, bronchial, and vascular walls, composed of tightly packed cells derived from the mononuclear phagocyte system. The clinical symptoms when present are dyspnea upon exertion, nonproductive cough, and wheezing. (Cecil Textbook of Medicine, 19th ed, p431)

Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.

Visualization of the heart structure and cardiac blood flow for diagnostic evaluation or to guide cardiac procedures via techniques including ENDOSCOPY (cardiac endoscopy, sometimes refered to as cardioscopy), RADIONUCLIDE IMAGING; MAGNETIC RESONANCE IMAGING; TOMOGRAPHY; or ULTRASONOGRAPHY.

Striated muscle cells found in the heart. They are derived from cardiac myoblasts (MYOBLASTS, CARDIAC).

Precursor cells destined to differentiate into cardiac myocytes (MYOCYTES, CARDIAC).

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