HEART-FID: Is intravenous ferric carboxymaltose helpful in HFrEF with iron deficiency?

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

Dr Robert Mentz (Duke University, NC, USA) outlined that the AFFIRM-AHF and IRONMAN trials, as well as meta-analyses, indicated that intravenous iron reduces the risk of HF hospitalisations without a significant effect on mortality [1–3]. “More evidence is needed with respect to the effect of FCM on clinical outcomes.” The multicentre, double-blind, phase 3 HEART-FID trial (NCT03037931) randomised 3,065 participants with HFrEF and iron deficiency 1:1 to intravenous FCM or a placebo [4]. The primary endpoint was a hierarchical composite of all-cause mortality at 12 months, HF hospitalisations at 12 months, and change in 6-minute walking distance (6MWD) at 6 months.

The primary endpoint was not significantly different at the significance threshold that was pre-specified for the trial (P=0.019). The corresponding rates for the individual aspects of the primary endpoint were:

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  • all-cause mortality at 12 months: FCM 8.6% versus placebo 10.3%;
  • HF hospitalisations at 12 months: FCM 13.3% versus placebo 14.8%; and
  • change in 6MWD at 6 months: FCM +8 metres versus placebo +4 metres.

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

Despite its neutral results, the presenting author stated, “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.” “FCM showed an acceptable safety profile and led to a modest, albeit non-significant, improvement in the primary endpoint.”

1. 
   
   1. Ponikowski P, et al. Lancet. 2020;396(10266):1895–1904.
   2. Kalra PR, et al. Lancet. 2022;400(10369):2199–2209.
   3. Ponikowski P, et al. Impact of ferric carboxymaltose (FCM) on heart failure-related clinical outcomes in patients with heart failure and iron deficiency: an individual participant data meta-analysis. Hot Line Session 2, ESC Congress 2023, 25–28 August, Amsterdam, the Netherlands.
   4. Mentz RJ, et al. The HEART-FID trial: efficacy and safety of ferric carboxymaltose as treatment for heart failure with iron deficiency. Hot Line Session 2, ESC Congress 2023, 25–28 August, Amsterdam, the Netherlands

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Posted on 30 October 202330 October 2023