Table 2.

Primary and secondary outcomes

Primary outcome

• Haemoglobin level at 16 weeks after randomization

Secondary outcomes The following items at 16 weeks after randomization:

• Red blood cell transfusion status

• Number of patients with an increase of at least 5 points on the KCCQ‐TSS relative to baseline

• Blood tests: NT‐proBNP, high‐sensitivity troponin T, serum iron, transferrin, total iron binding capacity, transferrin saturation, ferritin, hepcidin, high‐sensitivity C‐reactive protein, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, TNF‐α, IL‐1β, and VEGF (plasma), and angiopoietin

• Echocardiography: left and right ventricular function analysis, performed in the following cross sections, using M‐mode, colour Doppler, tissue Doppler, and strain analysis

• Cardiac MRI: left and right heart function, including strain analysis on cine MRI, native T1 abnormality, and extracellular volume fraction on T1 mapping

Abbreviations: HDL, high density lipoprotein; IL‐1β, interleukin 1 beta; KCCQ‐TSS, Kansas City Cardiomyopathy Questionnaire total symptom score; LDL, low density lipoprotein; MRI, magnetic resonance imaging; NT‐proBNP, N‐terminal pro‐brain natriuretic peptide; TNF‐α, tumour necrosis factor alpha; VEGF, vascular endothelial growth factor.