Treatment of Acute Pericarditis With Anakinra

Phase

Condition

Chest Pain

Cardiovascular Disease

Heart Disease

Treatment

N/A

Clinical Study ID

NCT03224585

HM20008638

Ages > 12
All Genders

Study Summary

The goal of this study is to determine the safety and efficacy of anakinra for the treatment of acute pericarditis when initiated within 6 hours of diagnosis and continued for 3 or 7 days.

to determine the efficacy of anakinra with respect to chest pain resolution
to determine the safety of anakinra with respect to adverse drug events

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age ≥12 years in presence of a parent able to provide consent or age >18 years
First or recurrent episode of acute pericarditis, defined as the presence of at least 2 of the following:
Chest pain (suggestive of pericarditis and not explained by another condition)
Pericardial friction rub on physical exam
ST-segment elevation and/or PR depression on ECG
New or worsening pericardial effusion
Pain of moderate-to-severe intensity (pain score ≥6 on a scale of 0-10 where 0 is nopain at all and 10 is the worst pain ever experienced) at time on enrollment
Ability to provide written informed consent if 18 years or older or to provide assentin presence of parental consent if 12-17 years of age

Exclusion

Exclusion Criteria:

Pericarditis due to known bacterial or fungal infection
Pericarditis due to known malignancy
Pericarditis after cardiac surgery
Tamponade or need for pericardiocentesis for diagnostic/therapeutic purposes
Pregnancy or breastfeeding
Hypersensitivity to anakinra, latex or products derived from Escherichia coli
Chronic pain syndrome or chronic use of analgesic drugs

Study Design

May 11, 2018

February 01, 2020

Study Description

Acute pericarditis is a clinical syndrome characterized by a profound inflammation of the membrane tissue that surrounds, supports and protects the heart. Acute pericarditis can be caused by a variety of infectious and non-infectious agents, but it most commonly either follows a viral infection of the upper respiratory tract or has no apparent cause.

Acute pericarditis occurs rather abruptly in previously healthy individuals, generally a child or young adult. Most cases of acute pericarditis resolve within a few days with non-steroidal anti-inflammatory drugs. However, patients experience severe chest pain and are at high risk for life-threatening complications involving the pericardium, such as pericardial tamponade. Acute pericarditis is diagnosed in 1 in 20 (5%) ED visits for chest pain.

Anakinra (Kineret) has been shown to treat and cure refractory and recurrent pericarditis. This study is aimed at determining whether anakinra is also effective as first line treatment in acute pericarditis.

Connect with a study center

Virginia Commonwealth University
Richmond, Virginia 23298
United States
Site Not Available

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