Intravenous ferric carboxymaltose shows long-term safety and clinical benefits in patients with HFrEF and iron deficiency, the HEART-FID study found.

Although the HEART-FID trial narrowly missed its primary endpoint, the authors concluded that the totality of evidence on intravenous ferric carboxymaltose (FCM) demonstrates the safety and clinical benefits of this therapy in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency.

At ESC Congress 2023, Robert Mentz, MD, outlined that the AFFIRM-AHF and IRONMAN trials, as well as meta-analyses indicated that intravenous iron reduces the risk of HF hospitalizations. “More evidence is needed with respect to the effect of FCM on clinical outcomes.” The multicenter, double-blind phase 3 HEART-FID trial randomly assigned 3,065 participants 1:1 to intravenous FCM or to placebo. The primary endpoint was a hierarchical composite of all-cause mortality at 12 months, HF hospitalizations at 12 months, and change in 6-minute walk distance (6MWD) at 6 months.

The primary endpoint narrowly missed the P=0.01 significance threshold that was set for this trial (P=0.019). The corresponding rates for the individual aspects of the primary endpoint were as follows: all-cause mortality at 12 months (FCM 8.6% vs placebo 10.3%); HF hospitalizations at 12 months (FCM 13.3% vs placebo 14.8%); and change in 6MWD at 6 months (FCM +8 meters vs placebo +4 meters).

Treatment-emergent adverse event rates were similar in participants receiving FCM and those receiving placebo (27.0% vs 26.2%).

“The HEART-FID trial is the largest study to evaluate the long-term safety and efficacy of intravenous FCM in patients with HFrEF and iron deficiency,” said Dr. Mentz. “FCM showed an acceptable safety profile and led to a modest, albeit nonsignificant, improvement in the primary endpoint. Together with prior studies, this trial confirms the overall safety and clinical benefits of intravenous FCM in patients with HFrEF and iron deficiency.”

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