Rationale and design of the IRON-HF study: a randomized trial to assess the effects of iron supplementation in heart failure patients with anemia.
BACKGROUND
Anemia is a common finding in heart failure (HF) patients and has been associated with increased morbidity and mortality. It is generally denominated as anemia of chronic disease (ACD), but the association with true ferropenic anemia is common. Many studies have investigated the effects of treating anemia in HF patients with either erythropoietin alone or combination of erythropoietin and intravenous iron. However, the effect of iron supplementation alone in HF patients with ACD, ferropenic anemia, or both is unknown.


RESULTS
IRON-HF study is a multicenter, investigator initiated, randomized, double-blind, placebo controlled trial that will enroll anemic HF patients with relatively preserved renal function, low transferrin saturation, low iron levels, and low to moderately elevated ferritin levels. Interventions are iron sucrose intravenously 200 mg once per week for 5 weeks, ferrous sulfate 200 mg by mouth 3 times per day for 8 weeks, or placebo. The primary objective is to assess the impact of iron supplementation (intravenously or by mouth) compared with placebo in HF patients with anemia from deficient iron availability. The primary end point is variation of peak oxygen consumption assessed by ergospirometry over 3-month follow-up. Secondary end points include functional class, brain natriuretic peptide levels, quality of life scores, left ventricular ejection fraction, adverse events, HF hospitalization, and death.


CONCLUSIONS
The results of IRON-HF should help to clarify the potential clinical impact of mild to moderate anemia correction in HF patients.
Beck-da-Silva
Luís
L
Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Rohde
Luís Eduardo
LE
Pereira-Barretto
Antônio Carlos
AC
de Albuquerque
Denílson
D
Bocchi
Edimar
E
Vilas-Boas
Fábio
F
Moura
Lídia Zytynzki
LZ
Montera
Marcelo W
MW
Rassi
Salvador
S
Clausell
Nadine
N
D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005290:Ferric Compounds / Q000627:therapeutic use*; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid; D006333:Heart Failure / Q000150:complications*; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D011446:Prospective Studies; D012107:Research Design
D005290:Ferric Compounds; D006397:Hematinics; C024823:ferric sulfate; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid