Clinical trial NCT03224585: Treatment of Acute Pericarditis With Anakinra
Official title: Treatment of Acute Pericarditis With Anakinra
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Pericarditis
Keywords: anakinra
Kineret
pericarditis
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 5
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Detailed 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.

Eligibility criteria: 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 no pain 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 assent in presence of parental consent if 12-17 years of age

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

Primary outcomes:
measure: Pain Score
timeFrame: Baseline to 6 hours
Secondary outcomes:
measure: Pain Score
timeFrame: Baseline to 24 hours
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Antonio Abbate, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wohlford GF, Buckley LF, Vecchie A, Kadariya D, Markley R, Trankle CR, Chiabrando JG, de Chazal HM, Van Tassell B, Abbate A. Acute Effects of Interleukin-1 Blockade Using Anakinra in Patients With Acute Pericarditis. J Cardiovasc Pharmacol. 2020 Jul;76(1):50-52. doi: 10.1097/FJC.0000000000000847.