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Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Heart Failure

NCT ID: NCT01300650

Last Updated: 2017-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-08-31

Brief Summary

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This is an open-label, non-randomized, pilot-study to evaluate the effect of Interleukin-1 blockade on exercise capacity in patients with heart failure. Subjects will undergo cardiopulmonary exercise testing at baseline and after 2-weeks treatment with anakinra (recombinant human Interleukin-1 receptor antagonist).

Detailed Description

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Conditions

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Heart Failure

Keywords

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Heart failure Inflammation Interleukin-1 Cardiopulmonary exercise

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anakinra

Group Type EXPERIMENTAL

Anakinra

Intervention Type DRUG

Anakinra 100 mg subcutaneous injection daily

Interventions

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Anakinra

Anakinra 100 mg subcutaneous injection daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of heart failure
* Recent echocardiogram documenting left ventricular ejection fraction \<40%
* High sensitivity C-reactive protein \>2 mg/L.

Exclusion Criteria

* 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 12 months
* 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 or baseline ECG changes that limit the ability to detect ischemia (i.e. left bundle-branch block).
* 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, active infection, or any comorbidity limiting survival or ability to complete the study
* Severe kidney dysfunction (eGFR \<30 mL/min)
* Coagulopathy (INR \>1.5), thrombocytopenia (\<50,000/mm3), or leukopenia (absolute neutrophil count \<1,500/mm3)
* Pregnancy (female patients will be required to take a urine pregnancy test)
* Latex or rubber allergy
* Inability to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin W Van Tassell, PharmD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Van Tassell BW, Arena RA, Toldo S, Mezzaroma E, Azam T, Seropian IM, Shah K, Canada J, Voelkel NF, Dinarello CA, Abbate A. Enhanced interleukin-1 activity contributes to exercise intolerance in patients with systolic heart failure. PLoS One. 2012;7(3):e33438. doi: 10.1371/journal.pone.0033438. Epub 2012 Mar 16.

Reference Type DERIVED
PMID: 22438931 (View on PubMed)

Other Identifiers

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1KL2RR031989-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AIR-HF Pilot Study

Identifier Type: -

Identifier Source: org_study_id