- Question
- Does intravenous ferric carboxymaltose improve clinical events and functional capacity in ambulatory patients with heart failure with reduced ejection fraction and iron deficiency?
- Design
- Randomized, double-blind, placebo-controlled trial with 1:1 allocation of 3065 ambulatory patients; the significance level was set at 0.01.
- Population
- Ambulatory patients with heart failure, a left ventricular ejection fraction of 40% or less, and iron deficiency, receiving standard heart failure therapy.
- Intervention
- Intravenous ferric carboxymaltose (1532 patients), given every 6 months as needed based on iron indexes and hemoglobin (per the registry: two doses of 15 mg/kg, maximum 750 mg per dose, 7 days apart).
- Control
- Placebo (normal saline) on the same dosing schedule (1533 patients).
- Primary outcome
- Hierarchical composite of death within 12 months, hospitalizations for heart failure within 12 months, and change from baseline to 6 months in 6-minute walk distance.
- Results
- There was no apparent difference in the primary outcome (Wilcoxon-Mann-Whitney P = 0.02; unmatched win ratio 1.10; 99% CI 0.99 to 1.23). Death by month 12 occurred in 131 patients (8.6%) with ferric carboxymaltose and 158 (10.3%) with placebo.
- Safety
- Repeated dosing appeared safe with an acceptable adverse-event profile in most patients. Serious adverse events were similar: 413 patients (27.0%) with ferric carboxymaltose and 401 (26.2%) with placebo.
- Conclusion
- In ambulatory patients with heart failure with reduced ejection fraction and iron deficiency, ferric carboxymaltose showed no apparent difference from placebo in the hierarchical composite of death, heart failure hospitalization, and walk distance.
- Why it matters
- It added evidence on hard clinical events with intravenous iron in heart failure, which previously rested mainly on improvements in symptoms and quality of life, and tempered expectations about its benefit on events.
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