Rationale and design of a randomised trial of intravenous iron in patients with heart failure.

A trial of predischarge intravenous ferric carboxymaltose to patients who had been hospitalised with acute heart failure (AFFIRM-AHF)) suggested that treatment to 6 months might reduce the risk of recurrent hospitalisations for heart failure but not cardiovascular mortality when assessed at 52 weeks, although the effect on its primary endpoint, a composite of recurrent hospitalisations for heart failure and cardiovascular death, was of borderline significance. 6 A meta-analysis of seven randomised trials of patients with HFrEF and iron deficiency found that intravenous iron reduced the risk of hospitalisation for heart failure but was unable to demonstrate a reduction in cardiovascular mortality. 7 Major gaps in our knowledge remain, including the long-term benefits and safety of repeated administration of intravenous iron.

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