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Table 3 Major ongoing trials investigating intravenous iron in heart failure

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

  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 12 months CV mortality or hospitalisation for worsening HF for a minimum of 6 months after last patient recruited Incidence of death and incidence of hospitalisation for HF at 1 year
Change in 6-MWT distance from baseline to 6 months
Duration 1 year Event-driven; min. 1 year Min. 2.5 years (average 3 years per participant) Event driven; min 1 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
  1. HF heart failure, CV cardiovascular, HFrEF heart failure with reduced ejection fraction, HFpEF heart failure with preserved 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, min minimum