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

Completed · Not applicable · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01542502

Run by

Virginia Commonwealth University

People needed

12

Starts

2012-02-01

Expected to finish

2013-06-01

Last updated by the study team

2017-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Atrial Fibrillation
• Left Atrial Enlargement
• E/A <0.5 + Deceleration Time (DT) >280 (if >50yrs of age)
• Biomarkers
• Brain Natriuretic Peptide (BNP) >200pg/mL

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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