Heart failure & cardiomyopathies
Resolution of Systemic Inflammation in Patients With Recently Decompensated Heart Failure With Reduced Ejection Fraction With and Without Interleukin-1 Blockade by Anakinra
Primary result · Peak VO2 changeResult — go to the resultMedian difference +0.30 mL·kg⁻1·min⁻1 95% CI −1.70 to +0.90Authors' conclusion
Patients with recently decompensated HFrEF treated with maximally tolerated medical therapy had a significant improvement in CRP and peak VO2. The addition of anakinra had a modest effect on CRP levels and no significant effect on peak VO2 or other clinically relevant secondary end points.
Study context
- Population
- Adults recently hospitalised for heart failure with reduced ejection fraction (HFrEF) with CRP ≥2 mg/L84 with primary end point data
- Participants
- 102 participants
- Comparison
- Anakinra vs placebo
- Anakinran = 68
- Placebon = 34reference
- Primary endpoint
- Change in peak VO2
- Follow-up
- 24 weeks
Methodological detailsplacebo-controlled, 2:1 randomisation
- Placebo-controlled
- 2:1 randomisation
Primary result
Peak VO2 change
Median difference
+0.30 mL·kg⁻1·min⁻1
95% CI −1.70 to +0.90
P = 0.40
Change by group
Anakinra
+1.5
median · IQR −0.2, +3.4 · mL·kg⁻1·min⁻1
Placebo
+1.2
median · IQR +0.5, +3.9 · mL·kg⁻1·min⁻1
As reported in the abstract
Secondary outcomes
CRP<2 mg/L achieved
P = 0.48
Median
| Outcome | Anakinra | Placebo | P value |
|---|---|---|---|
| CRP change | −76% (IQR −87%–-36%) | −48% (IQR −77%, +14%) | P = 0.050 |
| Peak VO2 change and HFrEF-related events, by CRP<2 vs ≥2 mg/L achievedCRP<2 mg/L vs CRP≥2 mg/L · peak VO2 | P = 0.007 | ||
| Peak VO2 change and HFrEF-related events, by CRP<2 vs ≥2 mg/L achievedCRP<2 mg/L vs CRP≥2 mg/L · HFrEF-related events | P = 0.045 |
- Peak VO2 change and HFrEF-related events, by CRP<2 vs ≥2 mg/L achieved: CRP<2 mg/L median +2.6 (IQR +0.7, +4.6) mL·kg⁻1·min⁻1 · HFrEF-related events 8%
- Peak VO2 change and HFrEF-related events, by CRP<2 vs ≥2 mg/L achieved: CRP≥2 mg/L median +1.0 (IQR −0.3, +1.9) mL·kg⁻1·min⁻1 · HFrEF-related events 26%
Peak VO2, entire cohort
- Peak VO2 increased from 13.0 (10.9, 17.0) to 14.9 (12.0, 18.0) mL·kg⁻1·min⁻1
- P < 0.001
Safety
- No unexpected treatment-related serious adverse events; no differences in HFrEF events between groups
Original publication
Resolution of Systemic Inflammation in Patients With Recently Decompensated Heart Failure With Reduced Ejection Fraction With and Without Interleukin-1 Blockade by Anakinra. Circ Heart Fail. Published 23 December 2025. doi:10.
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