Table 3 Major ongoing trials investigating intravenous iron in heart failure
From: Iron replacement therapy in heart failure: a literature review
| Â | FAIR-HFpEF [50] | FAIR-HF2 [52] | IRONMAN [51] | HEART-FID [53] |
|---|---|---|---|---|
ClinicalTrials.gov identifier | NCT03074591 | NCT03036462 | NCT02642562 | NCT03037931 |
Actual Study Start Date | August 1, 2017 | February 7, 2017 | August 2016 | March 15, 2017 |
Estimated study completion date | July 2021 | December 2021 | March 2022 | March 2023 |
HF diagnosis | HFpEF | HFrEF | HFrEF | HFrEF |
Number of participants | 200 | 1200 | 1300 | 3014 |
Randomisation and preparation | 1:1 FCM: placebo | 1:1 FCM: placebo | 1:1 Iron (III) isomaltoside: placebo | 1:1 FCM: placebo |
Blinding | Double-blind | Double-blind | Open label | Double-blind |
Primary Outcomes | Change in 6-MWT distance from baseline to week 24 | Combined rate of recurrent hospitalisations for HF and of CV death from baseline to at least 12Â months | CV mortality or hospitalisation for worsening HF for a minimum of 6Â months after last patient recruited | Incidence of death and incidence of hospitalisation for HF at 1Â year Change in 6-MWT distance from baseline to 6Â months |
Duration | 1Â year | Event-driven; min. 1Â year | Min. 2.5Â years (average 3Â years per participant) | Event driven; min 1Â year |
Important inclusion criteria | HFpEF with LVEF ≥ 45% NYHA class II or III Either hospitalised for HF within 12 months or raised NT-proBNP Hb > 9.0 g/dL and ≤ 14.0 g/dL | Chronic heart failure for at least 12 months Serum Hb 9.5–14 g/dL | LVEF < 45% NYHA class II–IV Current or recent (within 6 months) hospitalisation for HF Raised NT-proBNP | LVEF ≤ 40% NYHA II–IV Hb > 9.0 g/dL and < 13.5 g/dL (females) or < 15.0 g/dL (males)Either hospitalised for HF within 12 months or elevated NT-proBNP |
Definition of ID | Serum ferritin < 100 ng/mL, or ferritin 100–299 plus TSAT < 20% | Serum ferritin < 100 ng/ml, or serum ferritin 100–299 ng/ml with TSAT < 20% | TSAT < 20% and/or ferritin < 100 ug/L | Ferritin < 100 ng/mL or 100 to 300 ng/mL with TSAT < 20% |
Dosage | 500–2000 mg FCM according to Hb and weight | 1000–2000 mg FCM according to Hb and weight | Iron (III) isomaltoside 1,000-2000 mg according to Hb and body weight | Up to 750–1500 mg FCM according to Hb and weight |