Phase 2
Completed N=8
Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Heart Failure
Source: ClinicalTrials.gov NCT01300650 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Median Interval Change From Baseline in Peak VO2 — 3.90 mL/kg/min
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Interval Change From Baseline in Peak VO2 |
3.90 | — |
| PRIMARY Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) |
-2.10 | — |
| SECONDARY Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI) |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of heart failure
- Recent echocardiogram documenting left ventricular ejection fraction 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 ( 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
Data sourced from ClinicalTrials.gov (NCT01300650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.