Rationale and design of Ferinject((R)) Assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia

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Rationale and design of Ferinject((R)) Assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia. / Anker, Stefan D.; Colet, Josep Comin; Filippatos, Gerasimos; Willenheimer, Ronnie; Dickstein, Kenneth; Drexler, Helmut; Luescher, Thomas F.; Mori, Claudio; Rothe, Barbara von Eisenhart; Pocock, Stuart; Poole-Wilson, Philip A.; Ponikowski, Piotr.

In: European Journal of Heart Failure, Vol. 11, No. 11, 2009, p. 1084-1091.

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Anker, S. D., Colet, J. C., Filippatos, G., Willenheimer, R., Dickstein, K., Drexler, H., Luescher, T. F., Mori, C., Rothe, B. V. E., Pocock, S., Poole-Wilson, P. A., & Ponikowski, P. (2009). Rationale and design of Ferinject((R)) Assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia. European Journal of Heart Failure, 11(11), 1084-1091. https://doi.org/10.1093/eurjhf/hfp140

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Anker, Stefan D. ; Colet, Josep Comin ; Filippatos, Gerasimos ; Willenheimer, Ronnie ; Dickstein, Kenneth ; Drexler, Helmut ; Luescher, Thomas F. ; Mori, Claudio ; Rothe, Barbara von Eisenhart ; Pocock, Stuart ; Poole-Wilson, Philip A. ; Ponikowski, Piotr. / Rationale and design of Ferinject((R)) Assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia. In: European Journal of Heart Failure. 2009 ; Vol. 11, No. 11. pp. 1084-1091.

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TY - JOUR

T1 - Rationale and design of Ferinject((R)) Assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia

AU - Anker, Stefan D.

AU - Colet, Josep Comin

AU - Filippatos, Gerasimos

AU - Willenheimer, Ronnie

AU - Dickstein, Kenneth

AU - Drexler, Helmut

AU - Luescher, Thomas F.

AU - Mori, Claudio

AU - Rothe, Barbara von Eisenhart

AU - Pocock, Stuart

AU - Poole-Wilson, Philip A.

AU - Ponikowski, Piotr

PY - 2009

Y1 - 2009

N2 - Iron deficiency (ID) and anaemia are common in patients with chronic heart failure (CHF). The presence of anaemia is associated with increased morbidity and mortality in CHF, and ID is a major reason for the development of anaemia. Preliminary studies using intravenous (i.v.) iron supplementation alone in patients with CHF and ID have shown improvements in symptom status. FAIR-HF (Clinical Trials.gov NCT00520780) was designed to determine the effect of i.v. iron repletion therapy using ferric carboxymaltose on self-reported patient global assessment (PGA) and New York Heart Association (NYHA) in patients with CHF and ID. This is a multi-centre, randomized, double-blind, placebo-controlled study recruiting ambulatory patients with symptomatic CHF with LVEF < 40% (NYHA II) or < 45% (NYHA III), ID [ferritin < 100 ng/mL or ferritin 100-300 ng/mL when transferrin saturation (TSAT) < 20%], and haemoglobin 9.5-13.5 g/dL. Patients were randomized in a 2:1 ratio to receive ferric carboxymaltose (Ferinject((R))) 200 mg iron i.v. or saline i.v. weekly until iron repletion (correction phase), then monthly until Week 24 (maintenance phase). Primary endpoints are (i) self-reported PGA at Week 24 and (ii) NYHA class at Week 24, adjusted for baseline NYHA class. This study will provide evidence on the efficacy and safety of iron repletion with ferric carboxymaltose in CHF patients with ID with and without anaemia.

AB - Iron deficiency (ID) and anaemia are common in patients with chronic heart failure (CHF). The presence of anaemia is associated with increased morbidity and mortality in CHF, and ID is a major reason for the development of anaemia. Preliminary studies using intravenous (i.v.) iron supplementation alone in patients with CHF and ID have shown improvements in symptom status. FAIR-HF (Clinical Trials.gov NCT00520780) was designed to determine the effect of i.v. iron repletion therapy using ferric carboxymaltose on self-reported patient global assessment (PGA) and New York Heart Association (NYHA) in patients with CHF and ID. This is a multi-centre, randomized, double-blind, placebo-controlled study recruiting ambulatory patients with symptomatic CHF with LVEF < 40% (NYHA II) or < 45% (NYHA III), ID [ferritin < 100 ng/mL or ferritin 100-300 ng/mL when transferrin saturation (TSAT) < 20%], and haemoglobin 9.5-13.5 g/dL. Patients were randomized in a 2:1 ratio to receive ferric carboxymaltose (Ferinject((R))) 200 mg iron i.v. or saline i.v. weekly until iron repletion (correction phase), then monthly until Week 24 (maintenance phase). Primary endpoints are (i) self-reported PGA at Week 24 and (ii) NYHA class at Week 24, adjusted for baseline NYHA class. This study will provide evidence on the efficacy and safety of iron repletion with ferric carboxymaltose in CHF patients with ID with and without anaemia.

KW - Ferric

KW - Treatment

KW - Anaemia

KW - Chronic heart failure

KW - Iron deficiency

KW - carboxymaltose

U2 - 10.1093/eurjhf/hfp140

DO - 10.1093/eurjhf/hfp140

M3 - Article

VL - 11

SP - 1084

EP - 1091

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

SN - 1879-0844

IS - 11

ER -