Ferric Carboxymaltose Tx Examined in Chronic HF Patients With Iron Deficiency

Individuals were randomized 1:1 to receive FCM for 24 weeks or standard of care treatment
Individuals were randomized 1:1 to receive FCM for 24 weeks or standard of care treatment

For heart failure (HF) patients with an iron deficiency, iron stores are improved following administration of intravenous ferric carboxymaltose (FCM), according to results of a recent prospective, randomized, open-label study.

The aim of the study was to determine the effect of FCM administration on peak oxygen consumption (peak VO2), a measure of exercise capacity, in patients with HF and iron deficiency. One hundred seventy two patients with systolic HF experiencing mild to moderate symptoms despite optimal use of HF medications were analyzed.

They were randomized 1:1 to receive FCM for 24 weeks (n=86) or standard of care treatment (n=86; control group). The primary outcome of the study was peak VO2 change from baseline to 24 weeks. Quality of life, safety, and hematinic and cardiac biomarker effects were the secondary endpoints of the study. 

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Mean age at baseline was 64 years, mean left ventricular ejection fraction was 32% and peak VO2 was 13.5mL/min/kg. Seventy-five percent were men.

Results demonstrated that both serum ferritin as well as transferrin saturation were significantly increased after FCM administration. Additionally, peak VO2 was found to have decreased at 24 weeks for patients in the control group (least square means -1.19±0.389mL/min/kg) but was relatively preserved in patients who received FCM (-0.16±0.387mL/min/kg) (P=0.020 between groups). The sensitivity analysis that excluded missing data also observed a larger peak VO2 decrease in patients in the control group compared to those who received FCM at 24 weeks (−0.63±0.375 mL/min/kg vs −0.16±0.373 mL/min/kg, respectively; P=0.23 between groups).

Improvement of iron stores occurred in HF patients with iron deficiency following intravenous administration of FCM. The authors added, “Although a favorable effect on peak VO2 was observed on FCM, compared with standard of care in the primary analysis, this effect was highly sensitive to the imputation strategy for peak VO2 among patients who died.”

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