Interleukin-1 Blockade in Recently Decompensated Heart Failure (RED-HART)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Virginia Commonwealth University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01936909
First received: September 3, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1 blocker) in patients with recently decompensated heart failure to determine the safety and efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a cardiopulmonary exercise test.


Condition Intervention Phase
Heart Failure
Drug: Anakinra (weeks 1-2)
Drug: Anakinra (weeks 3-12)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interleukin-1 Blockade in Recently Decompensated Heart Failure: A Randomized Placebo-controlled Double-blinded Study

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Placebo-corrected interval changes in peak VO2 and VE/VCO2 slope [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Placebo-corrected changes in peak oxygen consumption (VO2) and ventilatory efficiency (VE/VCO2 slope) after 2 weeks of anakinra treatment.


Secondary Outcome Measures:
  • Quality of life improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    The Duke Activity Status Index and the Minnesota Living with Heart Failure questionnaires will be completed at enrollment, and then at weeks 2, 4, 12 and 24

  • Survival free of hospital admission [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    We will monitor survival status, and admissions (for any reasons, and for heart failure) at 2, 4, 12 and 24 weeks


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anakinra (short)
Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks
Drug: Anakinra (weeks 1-2)
Anakinra 100 mg daily for weeks 1 and 2
Experimental: Anakinra (long)
Anakinra 100 mg daily for 12 weeks
Drug: Anakinra (weeks 1-2)
Anakinra 100 mg daily for weeks 1 and 2
Drug: Anakinra (weeks 3-12)
Other Name: Anakinra 100 mg daily for weeks 3 through 12
Placebo Comparator: Placebo
Placebo injections daily for 12 weeks

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All 6 criteria need to be met for enrollment of the patient in the study

  1. Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed below:

    1. dyspnea or respiratory distress or tachypnea at rest or with minimal exertion;
    2. evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met);

      • pulmonary congestion/edema at physical exam OR chest XRay;
      • plasma BNP levels ≥200 pg/ml;
      • invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg.
  2. The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months).
  3. The patient is now clinically stable and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below:

    1. absence of dyspnea or pulmonary congestion/distress at rest;
    2. absence of pitting edema in the lower extremities, or in any other region;
    3. stable hemodynamic parameters (blood pressure, heart rate).
  4. The patient is of age ≥21 years old, and is willing and able to provide written informed consent.
  5. The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).
  6. The patient has screening plasma C-reactive protein levels >2 mg/L.

Exclusion Criteria Subjects will not be eligible if they meet any of the following 15 exclusion criteria.

  1. The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
  2. Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes, uncontrolled hypertention or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration.
  3. Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries.
  4. Previous or planned implantation of left ventricular assist devices or heart-transplant.
  5. Chronic use of intravenous inotropes.
  6. Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including NSAIDs).
  7. Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus).
  8. Active infection (of any type);
  9. Chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS).
  10. Prior (within the past 10 years) or current malignancy.
  11. Any comorbidity limiting survival or ability to complete the study.
  12. End stage kidney disease requiring renal replacement therapy.
  13. Neutropenia (<2,000/mm3) or Thrombocytopenia (<50,000/mm3).
  14. Pregnancy.
  15. Angina, arrhythmias, or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936909

Contacts
Contact: Antonio Abbate, MD, PhD 804-828-0513 aabbate@vcu.edu
Contact: Benjamin Van Tassell, PharmD 804-828-4583 bvantassell@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Antonio Abbate, MD, PhD    804-828-0513    aabbate@vcu.edu   
Contact: Benjamin W Van Tassell, PharmD    804-828-4583    bvantassell@vcu.edu   
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Antonio Abbate, MD, PhD    804-828-0513      
Contact: Benjamin Van Tassell, PharmD    804-982-0997      
Principal Investigator: Antonio Abbate, MD, PhD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Antonio Abbate, MD, PhD Virginia Commonwealth University
Principal Investigator: Benjamin W Van Tassell, PharmD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01936909     History of Changes
Other Study ID Numbers: RED-HART (HM15339), 1R34HL117026
Study First Received: September 3, 2013
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board

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 August 28, 2014