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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: American Heart Association
• Treatments: Interleukin 1 Receptor Antagonist Protein

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:

1. Invasive Hemodynamic measurements

• mean Pulmonary Capillary Wedge pressure (mPCW) >12

• Left Ventricular End Diastolic Pressure (LVEDP) >16 mmHg

2. Tissue Doppler Echocardiogram

• E/E' >15

• E/E' 8-15 and one of the following

• Left Ventricular Hypertrophy (LVH)

• Atrial Fibrillation

• Left Atrial Enlargement

• E/A <0.5 + Deceleration Time (DT) >280 (if >50yrs of age)

3. Biomarkers

• Brain Natriuretic Peptide (BNP) >200pg/mL

Exclusion Criteria:

• Age <18

• 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