Table 1 Current published randomised controlled trials investigating intravenous iron in heart failure
From: Iron replacement therapy in heart failure: a literature review
| Â | 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 12Â weeks | Composite of total HF hospitalisations and CV death up to 52Â weeks after randomisation |
Duration of follow-up | 24Â weeks | 18Â weeks | 24Â weeks | 52Â weeks | 24Â weeks | 12Â weeks | 52Â 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% |