Interleukin-1 Receptor Antagonist for the Treatment of Heart Failure in Patients with Left Ventricular Assist Devices

Principal Investigator: Aaron Healy
Keywords: LVAD , heart failure , recovery , Anakinra , Interleukin-1 Department: Surgery SOM
IRB Number: 00075500 Co Investigator:  
Specialty: Cardiothoracic Surgery, Cardiology, Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery, Cardiology, Cardiothoracic Surgery
Sub Specialties: Surgical Ventricular Restoration, General Cardiology, Heart Failure, Cardiac Mechanical Support, Heart Failure, Heart Transplant, Heart Transplant
Recruitment Status: Completed

Contact Information

Aaron Healy

Brief Summary

This pilot study will examine the biologic and clinical efficacy of the use of Anakinra in Left Ventricular Assist Device (LVAD) patients to address the following hypothesis and specific aims:

Hypothesis: The incidence and magnitude of myocardial recovery in patients with LVADS can be significantly improved through the administration of Anakinra.

Specific Aim 1: Determine the biologic and clinical efficacy of Anakinra in LVAD patients.

Sub Aim A: Determine biologic efficacy in the study group through the use of serial serum measurement of C-Reactive Protein, TNFα, neutrophil counts, and Interleukins 1β, 6, 10, and 18.

Sub Aim B: Determine clinical efficacy in the study group by measuring incidence and magnitude of echocardiographic myocardial recovery using changes in left ventricular ejection fraction, left ventricular end systolic volume, and left ventricular end diastolic volume compared at study onset and conclusion.

Specific Aim 2: Establish that exogenous Anakinra can be safely administered to LVAD patients.

Inclusion Criteria

To qualify for inclusion, patients must meet the following criteria: advanced heart failure patients at the University of Utah age >18 years at date of LVAD implantation who require circulatory support with an LVAD for either a bridge-to-transplant or destination therapy indication. They must also be judged by the implanting surgeon to have an expected survival to trial completion (approximately 6 months after implantation), without regard to the likelihood of cardiac transplantation.

Exclusion Criteria

Exclusion criteria include the presence of a Right Ventricular Assist Device (RVAD), as biventricular support is associated with decreased survival outcomes that could negatively impact the attrition rate over the course of the study. Additional exclusion criteria include the inability of the patient or a trained caregiver to administer the study drug, and inability of the patient to complete the study questionnaire. Patients with a creatinine clearance < 30 mL/min, evidence of an active infection, immunosuppression, or with an allergy to E. Coli derived products will also be excluded. Last, any patient with dependence on inflammatory modulating drugs will be excluded.