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

This study is currently recruiting participants.
Verified February 2012 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01542502
First received: February 23, 2012
Last updated: March 1, 2012
Last verified: February 2012
History of Changes
  Purpose

This will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of IL-1 blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.


Condition Intervention
Heart Failure
 Drug: Anakinra
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction

Resource links provided by NLM:

Drug Information available for: Anakinra
U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Peak oxygen consumption (peak VO2) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 14) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).


Secondary Outcome Measures:
  • Aerobic exercise parameters (VCO2, VE/VCO2 slope, exercise time) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Secondary endpoints will include interval change from baseline in other exercise parameters (peak VO2, exercise time, ventilatory efficiency) upon completion of 2 weeks treatment and throughout 4-week duration of study

  • Inflammatory biomarkers [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Secondary endpoints will include interval change from baseline in inflammatory biomarkers (high-sensitivity C-reactive protein, whole blood assay) upon completion of 2 weeks treatment and throughout 4-week duration of study.

  • Heart failure symptoms (DASI) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Secondary endpoints will include interval change from baseline in HF symptoms as measured by Duke Activity Status Index (DASI) upon completion of 2 weeks treatment and throughout the 4-week duration of study.

  • Adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Secondary endpoints will include assessment of adverse events and hospitalizations during 4-week duration of study.

  • Correlation between endpoints [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Secondary endpoints will include correlation studies between interval changes in biomarkers, exercise parameters, failure symptoms, adverse events and hospitalizations during 4-week duration of study.


Estimated Enrollment: 14
Study Start Date: February 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anakinra
Treatment with daily subcutaneous injections of Anakinra 100 mg
 Drug: Anakinra
Anakinra 100 mg daily subcutaneous injection
Other Names:
  • Recombinant human Interleukin-1 receptor antagonist
  • Kineret
Placebo Comparator: Placebo
Treatment with daily subcutaneous injection of placebo
 Drug: Placebo
Placebo daily subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms and signs of congestive heart failure
  • Recent Imaging Study (<12 months) showing LVEF>50% and LVEDVI<97ml/m2

  • Evidence of abnormal LV relaxation, filling, diastolic distensibility, and diastolic stiffness as shown by one of the following:

    1. Invasive Hemodynamic measurements

      • mPCW >12
      • LVEDP>16mmHg

    2. Tissue Doppler Echocardiogram

      • E/E' >15

      • E/E' 8-15 and one of the following

        • LVH
        • Afib
        • LAE
        • E/A<0.5+DT>280(if >50yrs of age)
    3. Biomarkers
  • 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 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542502

Contacts
Contact: Antonio Abbate, MD, PhD 804-828-0513

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Principal Investigator: Antonio Abbate, MD, PhD            
Sub-Investigator: Benjamin W Van Tassell, PharmD            
Sponsors and Collaborators
Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01542502     History of Changes
Other Study ID Numbers: HM14079
Study First Received: February 23, 2012
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Heart failure with preserved ejection fraction
Diastolic heart failure
Aerobic exercise performance

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Interleukin 1 Receptor Antagonist Protein
 Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2012