Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction

Virginia Commonwealth University1 site in 1 country12 target enrollmentFebruary 2012

ConditionsHeart Failure

InterventionsAnakinra Placebo

DrugsAnakinra Placebo

Overview

Phase: Not Applicable
Intervention: Anakinra
Conditions: Heart Failure
Sponsor: Virginia Commonwealth University
Enrollment: 12
Locations: 1
Primary Endpoint: Peak Oxygen Consumption (Peak VO2)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

June 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Virginia Commonwealth University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Symptoms and signs of congestive heart failure
•Recent Imaging Study (\<12 months) showing Left Ventricular Ejection Fraction (LVEF) \>50% and Left Ventricular End Diastolic Volume Index (LVEDVI) \<97ml/m2
•Evidence of abnormal Left Ventricular (LV) relaxation, filling, diastolic distensibility, and diastolic stiffness as shown by one of the following:
•Invasive Hemodynamic measurements
•mean Pulmonary Capillary Wedge pressure (mPCW) \>12
•Left Ventricular End Diastolic Pressure (LVEDP) \>16 mmHg
•Tissue Doppler Echocardiogram
•E/E' \>15
•E/E' 8-15 and one of the following
•Left Ventricular Hypertrophy (LVH)

Exclusion Criteria

•Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme \[ACE\] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
•Hospitalization for worsening Heart Failure (HF) or acute decompensated HF within the previous 12months
•Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD)
•Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing
•Active infection including chronic infection
•Active cancer
•Recent (\<14 days) use of anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs \[NSAIDs\]), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study
•Pregnancy (determined by urine pregnancy test in women of childbearing potential)
•Inability to give informed consent
•Other conditions limiting completion of cardiopulmonary exercise test or completion of the study

Arms & Interventions

Anakinra

Treatment with daily subcutaneous injections of Anakinra 100 mg

Intervention: Anakinra

Placebo

Treatment with daily subcutaneous injection of placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Peak Oxygen Consumption (Peak VO2)

Time Frame: 14 days

The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).