- Question
- Does intravenous iron (ferric derisomaltose) improve longer-term cardiovascular events in patients with heart failure, reduced ejection fraction and iron deficiency?
- Design
- Prospective, 1:1 randomised, open-label, blinded-endpoint trial (masked adjudication of outcomes) conducted at 70 hospitals in the UK. A total of 1137 patients were randomised, with a median follow-up of 2.7 years.
- Population
- Adults aged 18 years or older with heart failure and left ventricular ejection fraction ≤45%, with transferrin saturation <20% or serum ferritin <100 μg/L.
- Intervention
- Intravenous ferric derisomaltose, dosed according to bodyweight and haemoglobin concentration, on top of usual care.
- Control
- Usual care without intravenous iron.
- Primary outcome
- Composite of recurrent hospital admissions for heart failure and cardiovascular death.
- Results
- There were 336 primary endpoints (22.4 per 100 patient-years) with ferric derisomaltose and 411 (27.5 per 100 patient-years) with usual care (rate ratio 0.82; 95% CI 0.66 to 1.02; p=0.070), which did not reach statistical significance. In the COVID-19 sensitivity analysis (follow-up censored on Sept 30, 2020) the rate ratio was 0.76 (95% CI 0.58 to 1.00; p=0.047).
- Safety
- There were no between-group differences in deaths or hospitalisations due to infections. Cardiac serious adverse events were less frequent with intravenous iron (200 patients [36%]) than with usual care (243 [43%]; p=0.016).
- Conclusion
- Intravenous ferric derisomaltose was associated with a trend toward lower risk of heart failure hospitalisation and cardiovascular death, although the primary outcome was not statistically significant in the main analysis.
- Why it matters
- It strengthened the evidence supporting intravenous iron repletion in patients with heart failure, reduced ejection fraction and iron deficiency, in a real-world setting with longer follow-up.
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 14, 2026