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

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Heart Failure

Treatments

Drug: Anakinra

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01542502

HM14079

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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