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

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