Ferric Carboxymaltose in Heart Failure with Iron Deficiency

The HEART-FID trial was a randomized, double-blind study evaluating intravenous ferric carboxymaltose (FCM) versus placebo in 3065 ambulatory patients with heart failure (LVEF ≤40%) and iron deficiency. The hierarchical primary endpoint included 12-month all-cause death, heart failure hospitalizations, and change in 6-minute walk distance at 6 months. The unmatched win ratio for FCM vs. placebo was 1.10 (99% CI, 0.99–1.23; P=0.02), with slightly fewer deaths (8.6% vs. 10.3%) and hospitalizations (297 vs. 332) and modest walk distance improvement (+8 m vs. +4 m). The main secondary outcome CV death or first HF hospitalization over follow-up, showed no statistically significant difference (HR 0.93; 96% CI, 0.81–1.06). Adverse events were comparable between groups (serious AEs: 27.0% vs. 26.2%). Subgroup analyses revealed potential age- and renal-related heterogeneity. While FCM appeared safe and modestly beneficial, no clear impact on hard outcomes was demonstrated, prompting continued debate on iron repletion endpoints in chronic heart failure.

The HEART-FID trial was a randomized, double-blind study evaluating intravenous ferric carboxymaltose (FCM) versus placebo in 3065 ambulatory patients with heart failure (LVEF ≤40%) and iron deficiency. The hierarchical primary endpoint included 12-month all-cause death, heart failure hospitalizations, and change in 6-minute walk distance at 6 months. The unmatched win ratio for FCM vs. placebo was 1.10 (99% CI, 0.99–1.23; P=0.02), with slightly fewer deaths (8.6% vs. 10.3%) and hospitalizations (297 vs. 332) and modest walk distance improvement (+8 m vs. +4 m). The main secondary outcome CV death or first HF hospitalization over follow-up, showed no statistically significant difference (HR 0.93; 96% CI, 0.81–1.06). Adverse events were comparable between groups (serious AEs: 27.0% vs. 26.2%). Subgroup analyses revealed potential age- and renal-related heterogeneity. While FCM appeared safe and modestly beneficial, no clear impact on hard outcomes was demonstrated, prompting continued debate on iron repletion endpoints in chronic heart failure.