Ferric Carboxymaltose Among Patients with Heart Failure and Iron Deficiency: An Updated Meta-Analysis of Randomized Controlled Trials

Iron deficiency is common in heart failure and contributes to reduced exercise tolerance and worse outcomes. Ferric carboxymaltose offers targeted iron repletion, yet randomized trials have shown mixed results. This meta-analysis updates the evidence on its efficacy and safety in patients with heart failure and iron deficiency. Electronic databases were searched through December 2025 for RCTs that compared clinical outcomes with ferric carboxymaltose (FCM) versus control. The primary outcome was the composite heart failure hospitalization (HFH) or cardiovascular mortality. Summary estimates were constructed using a random effects model. Nine randomized clinical trials with 6,405 patients were included. FCM administration was associated with a lower incidence of composite HFH or cardiovascular mortality compared with the control group (risk ratio [RR] 0.86, 95% confidence interval [CI] 0.77 to 0.97, P = 0.014). There was a trend towards a lower incidence of HFH (RR 0.84, 95% CI 0.69 to 1.02, P = 0.07). There was no difference in the incidence of cardiovascular mortality (RR 0.88, 95% CI 0.75 to 1.03, P = 0.1) and all-cause mortality (RR 0.95, 95% CI 0.85 to 1.06, P = 0.38). FCM was associated with improvement in the 6MWT, with no significant change in KCCQ. Among patients with HF and iron deficiency, FCM was associated with a small but statistically significant lower incidence of HFH or cardiovascular mortality.