- Question
- Does intravenous ferric carboxymaltose, given to iron-deficient patients stabilised after an episode of acute heart failure, reduce heart failure hospitalisations and cardiovascular death?
- Design
- Multicentre, double-blind, randomised 1:1 placebo-controlled trial at 121 sites in Europe, South America, and Singapore. A total of 1132 patients were randomised before hospital discharge and followed for 52 weeks.
- Population
- Adults aged 18 years or older hospitalised for acute heart failure with iron deficiency (ferritin <100 μg/L, or 100-299 μg/L with transferrin saturation <20%) and a left ventricular ejection fraction below 50%.
- Intervention
- Intravenous ferric carboxymaltose for up to 24 weeks, with doses adjusted to the extent of iron deficiency; the first dose was given before discharge.
- Control
- Placebo (0.9% normal saline) given in black syringes to maintain masking.
- Primary outcome
- Composite of total heart failure hospitalisations and cardiovascular death up to 52 weeks after randomisation.
- Results
- There were 293 primary events (57.2 per 100 patient-years) with ferric carboxymaltose and 372 (72.5 per 100 patient-years) with placebo (rate ratio 0.79; 95% CI 0.62-1.01; p=0.059), which did not reach statistical significance. Total heart failure hospitalisations were lower with iron (rate ratio 0.74; 95% CI 0.58-0.94; p=0.013), with no difference in cardiovascular death (HR 0.96; 95% CI 0.70-1.32).
- Safety
- Serious adverse events occurred in 250 (45%) of 559 patients receiving ferric carboxymaltose and 282 (51%) of 551 receiving placebo.
- Conclusion
- In iron-deficient patients with reduced ejection fraction stabilised after acute heart failure, ferric carboxymaltose was safe and reduced heart failure hospitalisations with no apparent effect on cardiovascular death, although the primary endpoint did not reach statistical significance.
- Why it matters
- It added evidence on treating iron deficiency in the early period after a decompensation, highlighting fewer rehospitalisations and supporting systematic screening for iron deficiency in these patients.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026