Physicians' Academy for Cardiovascular Education

Iron supplementation maintains exercise capacity in heart failure with iron deficiency

Effect of Ferric Carboxymaltose on Exercise Capacity in Patients with Chronic Heart Failure and Iron Deficiency

van Veldhuisen DJ, Ponikowski P, van der Meer P, et al. - Circulation. 2017; published online ahead of print

Background

Up to 35-50% of heart failure (HF) patients have iron deficiency, which is associated with the severity of the disease, and is a strong and independent predictor of outcomes [1-3]. Studies showed that the administration of the intravenous (IV) iron agent ferric carboxymaltose (FCM) improved symptoms, outcomes, quality of life, and functional capacity measured with the 6 minutes walking test, irrespective of the presence of anemia [4,5].

In this prospective, randomized, controlled, multi-center, open-label trial, with blinded end-point evaluation, the effect of treatment with IV FCM on exercise capacity was assessed compared to standard of care, in patients with symptomatic chronic HF and iron deficiency.

Eligible patients had NYHA functional class II-III, left ventricle ejection fraction (LVEF) ≤45%, BNP >100 pg/mL and/or NT-proBNP >400 pg/mL, a VO2 of 10-20 mL/kg/min, serum ferritin <100 ng/mL or a serum ferritin of 100-300 ng/mL plus a transferrin saturation (TSAT) <20%, and were on optimal background therapy for HF for at least 4 weeks with no dose changes in the last 2 weeks.

After an initial screening period (up to 12 weeks) eligible subjects were randomized (1:1) to FCM or usual care for a period of 24 weeks. Dosing at day 0 and week 6 was based on screening hemoglobin (Hb) and weight, and not on ferritin and TSAT results. For patients in the standard of care group, oral iron was allowed.

The primary endpoint was the change in peak VO2 from baseline to 24 weeks. For the primary analysis, patients who died had a value of zero imputed for 24-week peak VO2. Secondary endpoints included the effect of FCM on hematinic indices (Hb, ferritin, and TSAT), natriuretic peptides (BNP and NTproBNP), NYHA functional class, and patient global assessment (PGA). In addition, safety parameters were collected.

Main results

Conclusion

In patients with chronic HF and iron deficiency, IV iron supplementation with FCM had a beneficial effect on peak VO2 compared to standard of care treatment, irrespective of the presence of baseline anemia. Moreover, FCM led to repletion of iron stores and improvement in measures of disease severity and quality of life.

References

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Find this article online at Circulation