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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Drug: Placebo; Drug: Anakinra

• Registration Number: NCT01542502
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2014-08-19
• Results First Submitted QC: 2016-03-04
• Results First Posted: 2016-04-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Treatment with daily subcutaneous injection of placebo
Anakinra	Anakinra	Treatment with daily subcutaneous injections of Anakinra 100 mg

Primary Outcome Measures

Name	Time	Method
Peak Oxygen Consumption (Peak VO2)	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).

Secondary Outcome Measures

Name	Time	Method
Exercise Time	14 days	Interval change from baseline in duration of exercise during a standardized cardiopulmonary exercise test upon completion of 2 weeks treatment

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States