Table 1.
Inclusion and exclusion criteria
| Inclusion criteria |
| 1. Symptomatic NYHA class II heart failure or a history of hospitalization due to heart failure |
| 2. Aged 20–90 years at the time of consent to participate |
| 3. eGFR of 〈60 ml/min/1.73 m2 at screening |
| 4. Patients without atrial fibrillation at screening: BNP > 100 pg/ml or NT‐proBNP >600 pg/ml; Patients with atrial fibrillation at screening: BNP > 150 pg/ml or NT‐proBNP >900 pg/ml |
| 5. Haemoglobin level of ≥7.5 and <11 g/dl at screening |
| 6. Ferritin level of ≥100 ng/ml and TSAT ≥20% at screening |
| 7. Folic acid and vitamin B12 levels above the lower limit of normal at screening |
| 8. Provided written consent to participate in the study |
| Exclusion criteria |
| 1. Severe heart failure (NYHA class III/IV) |
| 2. Haemodialysis or peritoneal dialysis at the time of consent, or scheduled within 6 months |
| 3. Treated with an ESA within 5 weeks before enrolment |
| 4. Red blood cell transfusion within 12 weeks before enrolment, or expected to occur during the study period |
| 5. A history of treatment with HIF‐PH inhibitors |
| 6. Anaemia due to reasons other than chronic kidney disease and current bleeding or bleeding within 3 months |
| 7. A history of sickle cell disease, myelodysplastic syndromes, myelofibrosis, haematologic tumours, myeloma, haemolytic anaemia, thalassaemia, or locus coeruleus tumour |
| 8. History of pulmonary hypertension or polycystic kidney disease |
| 9. Presence of a malignant tumour noted within 2 years, except for treated basal cell carcinoma of the skin, squamous cell carcinoma cured by resection, and intraepithelial carcinoma of the cervix |
| 10. History of acute myocardial infarction, cerebral infarction, deep vein thrombosis, or pulmonary thromboembolism within 48 weeks before enrolment |
| 11. Judged by the principal investigator to be inappropriate as a research subject |
Abbreviations: BNP, brain natriuretic peptide; eGFR, estimated glomerular filtration rate; ESA, erythropoiesis‐stimulating agent; HIF‐PH, hypoxia‐inducible factor‐prolyl hydroxylase; NYHA, New York Heart Association; NT‐proBNP, N‐terminal pro‐brain natriuretic peptide; TSAT, transferrin saturation