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Completed

NCT Number: NCT01542502

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure, Diastolic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

Anakinra

Drug

Anakinra 100 mg daily subcutaneous injection

Other names: Recombinant human Interleukin-1 receptor antagonist, Kineret

Placebo

Drug

Placebo daily subcutaneous injection

Other names: Sodium Chloride (NaCl) 0.9%

Primary outcomes

  1. Peak Oxygen Consumption (Peak VO2)

    Time frame: 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 outcomes

  1. Exercise Time

    Time frame: 14 days

    Interval change from baseline in duration of exercise during a standardized cardiopulmonary exercise test upon completion of 2 weeks treatment

Other outcomes

  1. Correlation Between Endpoints

    Time frame: 28 days

    Correlation between interval change in peak VO2 and high sensitivity C-reactive protein

  2. Heart Failure Symptoms (DASI)

    Time frame: 28 days

    Interval change from baseline in Heart Failure (HF) symptoms as measured by Duke Activity Status Index (DASI) upon completion of 2 weeks treatment.

  3. Adverse Events

    Time frame: 28 days

    Additional endpoints will include assessment of adverse events and hospitalizations during 4-week duration of study.

  4. Inflammatory Biomarkers

    Time frame: 28 days

    Interval change from baseline in high-sensitivity C-reactive protein upon completion of 2 weeks treatment.

  5. Ventilatory Efficiency (VE/VCO2 [Carbon Dioxide] Slope)

    Time frame: 14 days

    Interval change from baseline in ventilatory efficiency (VE/VCO2 slope) upon completion of 2 weeks treatment.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 2, 2012
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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