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

Virginia Commonwealth University (VCU)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Heart Failure

Treatments

Drug: Anakinra

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01300650

1KL2RR031989-01 (U.S. NIH Grant/Contract)

AIR-HF Pilot Study

Details and patient eligibility

About

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).

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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