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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/2/2017
Start Date:February 2011
End Date:August 2011

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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).


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
We found this trial at
1
site
Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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