Table 2.
Overview of RCT addressing the effect of IV iron on clinical outcomes in patients with chronic HF and ID
| Study | PMID | Year | Criteria for anaemia/iron status | Interventions (N) | Mean kidney function at baseline | Follow-up (weeks) | Outcome (intervention versus control) |
|---|---|---|---|---|---|---|---|
| Toblli et al. | 17950147 | 2007 | Hb <12.5 g/dL; TSAT <20%; Ferritin <100 μg/L | IV ISC (n = 20) IV saline (n = 20) | CrCl 39.8 ± 10.1 (ISC) CrCl 37.7 ± 10.2 mL/min (placebo) | 24 | NTproBNP↓ (P < 0.01) LVEF↑ (P < 0.01) HRQoL↑ (P < 0.01) 6 MWT↑ (P < 0.01) |
| FERRIC-HF | 18191732 | 2008 | Ferritin <100 μg/L or 100–300 μg/L with TSAT <20% | IV ISC (n = 24) Standard care (n = 11) | sCr 109 ± 42 µmol/L (ISC) sCr 104 ± 39 µmol/L (standard care) | 18 | pVO2↑ (NS, P = 0.08) NYHA↓ (P = 0.007) GAF↑ (P = 0.002) HRQoL (NS, P = 0.07) |
| FAIR-HF (+ post hoc studies) | 19920054 22297124 25683972 | 2009, 2015 | Ferritin <100 μg/L or 100–300 μg/L with TSAT <20% | IV FCM (n = 304) IV saline (n = 155) | eGFR 63.8 ± 21.2 mL/min (FCM) eGFR 64.8 ± 25.3 mL/min (placebo) | 26 | GAF↑ (P < 0.001) NYHA↓ (P < 0.001) 6 MWT↑ HRQoL↑ (P < 0.001) eGFR↑ (P = 0.04) |
| IRON-HF | 23680589 | 2013 | Hb 9–12 g/dL; ferritin <500 μg/L; TSAT <20% | IV ISC (n = 10) IV saline (n = 6) Oral FS (n = 7) | sCr 97 ± 27 µmol/L (total cohort) | 12 | pVO2 (NS) NYHA (NS) eGFR (NS) |
| CONFIRM-HF | 25176939 | 2015 | Hb <15 g/dL; Ferritin <100 μg/L or 100–300 μg/L with TSAT<20% | IV FCM (n = 150) IV saline (n = 151) | eGFR 66.4 ± 21.7 mL/min (FCM) eGFR 63.5 ± 20.9 mL/min (placebo) | 52 | 6 MWT↑ (P = 0.002) NYHA↓ (P < 0.001) GAF↑ (P = 0.001) HRQoL↑ (P < 0.05) Acute HF↓ (P = 0.009) |
| EFFECT-HF | 28701470 | 2017 | Hb <15 g/dL; Ferritin <100 μg/L or 100–300 μg/L with TSAT <20% | IV FCM (n = 86) Standard care (n = 86) | eGFR 52 ± 13 mL/min (FCM) eGFR 51 ± 12 mL/min (placebo) | 24 | pVO2↑ (P = 0.02)a GAF↑ (P < 0.05) NYHA↓ (P < 0.05) NTproBNP↓ (NS) |
a
Only significant after imputation.
FS: ferrous sulphate; VO2: peak VO2; HRQoL: health-related quality of life; NYHA: New York Heart Association Class; NTproBNP: N-terminal prohormone of brain natriuretic peptide; 6 MWT: six-minute walk test; GAF: Global Assessment of Functioning; NS: non-significant; CrCl: creatinine clearance; sCr: serum creatinine.