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Table 1 Current published randomised controlled trials investigating intravenous iron in heart failure

From: Iron replacement therapy in heart failure: a literature review

  Toblli et al FERRIC-HF FAIR-HF CONFIRM-HF EFFECT-HF PRACTICE-ASIA-HF AFFIRM-AHF
Publication year 2007 2008 2009 2014 2017 2018 2020
HF diagnosis HFrEF HFrEF HFrEF HFrEF HFrEF Acute decompensated HF Acute decompensated HF
Number of participants 40 35 459 301 172 49 1108
Randomisation and preparation 1:1 Iron sucrose: placebo 2:1 Iron sucrose: placebo 2:1 FCM:placebo 1:1 FCM:placebo 1:1 FCM:placebo 1:1 FCM:placebo 1:1 FCM:placebo
Blinding Double-blind Double-blind Double-blind Double-blind Open-label Single-blind Double-blind
Primary outcomes Change in NT-proBNP level and CRP Change in absolute pVO2 (ml/kg/min) from baseline to week 18 Changes in self-reported Patient Global Assessment and NYHA class from baseline to week 24 Change in 6-MWT distance from baseline to week 24 Change in peak VO2 (ml/min/kg) from baseline to week 24 Change in 6-MWT distance over 12 weeks Composite of total HF hospitalisations and CV death up to 52 weeks after randomisation
Duration of follow-up 24 weeks 18 weeks 24 weeks 52 weeks 24 weeks 12 weeks 52 weeks
Dosage IV Iron sucrose 200 mg weekly for 5 weeks IV Iron sucrose 200 mg weekly until ferritin > 500 ng/ml, then 200 mg monthly thereafter for a total of 16 weeks IV FCM 200 mg weekly until iron repletion achieved, then every 4 weeks thereafter IV FCM 500–2000 mg based on Hb and weight IV FCM 500–1000 mg based on Hb and weight Single dose of 1000 mg IV FCM 500–1500 mg FCM based on Hb and weight
Important inclusion criteria  LVEF ≤ 35%
 NYHA II–IV
 Hb < 12.5 g/dL for men and < 11.5 g/dL for women
 LVEF ≤ 45%
 NYHA II–III
 pVo2/kg ≤ 18 ml/kg/min
 Hb < 12.5 g/dL anaemic group; 12.5–14.5 g/dL non-anaemic group
 LVEF ≤ 45%
 NYHA II–III
 Hb between 9.5 and 13.5 g/dL
 LVEF ≤ 45%
NYHA II–III
 Elevated natriuretic peptides
 Hb < 15 g/dL
 LVEF ≤ 45%
 NYHA II–III
 Elevated natriuretic peptides
 Peak VO2 of 10–20 mL/kg/min
 Hospitalised for HF
 Hb ≤ 14 g/dL
 LVEF < 50%
 Hospitalised for HF
Definition of ID Serum ferritin < 100 ng/ml and/or with transferrin saturation (TSAT) ≤ 20% Serum ferritin < 100 μg/l, or between 100 and 300 μg/l if TSAT < 20% Serum ferritin < 100 μg/L, or between 100 and 299 μg/L if the TSAT < 20% Serum ferritin < 100 ng/mL, or between 100 and 300 ng/mL if TSAT < 20% Serum ferritin < 100 ng/mL. or between 100 and 300 ng/mL if TSAT < 20% Serum ferritin < 300 ng/mL if transferrin saturation is < 20% Serum ferritin < 100 ng/mL, or 100–299 ng/mL if TSAT < 20%
  1. HF heart failure, CV cardiovascular, HFrEF heart failure with reduced ejection fraction, FCM ferrous carboxymaltose, 6-MWT 6-min walk test, TSAT transferrin saturation, NYHA New York Heart Association, LVEF left ventricular ejection fraction, NT=proBNP N-terminal prohormone of brain natriuretic peptide, Hb haemoglobin, IV intravenous