Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01542502
Recruitment Status : Completed
First Posted : March 2, 2012
Results First Posted : April 7, 2016
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Anakinra Drug: Placebo Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Anakinra

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
Other Name: Sodium Chloride (NaCl) 0.9%


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542502


Locations
Layout table for location information
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
American Heart Association
Investigators
Layout table for investigator information
Principal Investigator: Antonio Abbate, MD, PhD Virginia Commonwealth University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01542502    
Other Study ID Numbers: HM14079
First Posted: March 2, 2012    Key Record Dates
Results First Posted: April 7, 2016
Last Update Posted: February 6, 2017
Last Verified: December 2016
Keywords provided by Virginia Commonwealth University:
Heart failure with preserved ejection fraction
Diastolic heart failure
Aerobic exercise performance
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents