Iron Deficiency, Non-Cardiac Intervention & Symptomatic Heart Failure

Research Paper Title

Beneficial Effects of Long-term Intravenous Iron Therapy with Ferric Carboxymaltose in Patients with Symptomatic Heart Failure and Iron Deficiency.

Background

The aim of this study was to evaluate the benefits and safety of long-term i.v. iron therapy in iron-deficient patients with heart failure (HF).

Methods

CONFIRM-HF was a multi-centre, double-blind, placebo-controlled trial that enrolled 304 ambulatory symptomatic HF patients with left ventricular ejection fraction ≤45%, elevated natriuretic peptides, and iron deficiency (ferritin <100 ng/mL or 100–300 ng/mL if transferrin saturation <20%). Patients were randomised 1 : 1 to treatment with i.v. iron, as ferric carboxymaltose (FCM, n = 152) or placebo (saline, n = 152) for 52 weeks. The primary end-point was the change in 6-min-walk-test (6MWT) distance from baseline to Week 24. Secondary end-points included changes in New York Heart Association (NYHA) class, Patient Global Assessment (PGA), 6MWT distance, health-related quality of life (QoL), Fatigue Score at Weeks 6, 12, 24, 36, and 52 and the effect of FCM on the rate of hospitalisation for worsening HF.

Results

Treatment with FCM significantly prolonged 6MWT distance at Week 24 (difference FCM vs. placebo: 33 ± 11 m, P = 0.002). The treatment effect of FCM was consistent in all subgroups and was sustained to Week 52 (difference FCM vs. placebo: 36 ± 11 m, P < 0.001). Throughout the study, an improvement in NYHA class, PGA, QoL, and Fatigue Score in patients treated with FCM was detected with statistical significance observed from Week 24 onwards. Treatment with FCM was associated with a significant reduction in the risk of hospitalisations for worsening HF [hazard ratio (95% confidence interval): 0.39 (0.19–0.82), P = 0.009]. The number of deaths (FCM: 12, placebo: 14 deaths) and the incidence of adverse events were comparable between both groups.

Conclusions

Treatment of symptomatic, iron-deficient HF patients with FCM over a 1-year period resulted in sustainable improvement in functional capacity, symptoms, and QoL and may be associated with risk reduction of hospitalisation for worsening HF (ClinicalTrials.gov number NCT01453608).

My Note

This is an illustration that heart failure syndrome can often be helped by non-cardiac interventions.

Reference

, P., , D.J., , J., , G., , M., , V., , T., , A., , L., , V., , C., , B., , G., , F. & , S.D. (2014) Beneficial Effects of Long-term Intravenous Iron Therapy with Ferric Carboxymaltose in Patients with Symptomatic Heart Failure and Iron Deficiency. European Heart Journal. First published online: 31 August 2014. doi: http://dx.doi.org/10.1093/eurheartj/ehu385.

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