ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure (ORION-HF)

Inclusion Criteria

• •1. Men, women\*, inter/diverse aged ≥ 18 at day of inclusion
• •2. Signed written informed consent from patient prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
• •3. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
• •4. Patients with chronic heart failure with an Left ventricular ejection fraction (LVEF)\<50% (Heart failure with reduced ejection fraction (HFrEF), Heart failure with a mid-range ejection fraction (HFmrEF)) or patients with chronic heart failure with an EF≥50% (HFpEF) and New York Heart Association functional class II-IV
• •5. 6 min walk distance \>50 m
• •6. Mild-to-moderate anaemia and iron -deficiency as defined by a haemoglobin concentration ≥8 g/dl and \<12 g/dl in females or ≥9 g/dl and \<13 g/dl in males, and serum ferritin \<100 µg/l, or 100-299 µg/l and transferrin saturation \<20% at screening
• •7. \*Women without childbearing potential defined as follows:
• •* females before menarche (if applicable)
• •* at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
• •* hysterectomy or uterine agenesis or
• •* ≥ 50 years and in postmenopausal state \> 1 year or
• •* \< 50 years and in postmenopausal state \> 1 year with serum Follicle stimulating hormone (FSH) \> 40 IU/l and serum estrogen \< 30 ng/l or a negative estrogen test, both at screening or
• •\*Women of childbearing potential:
• •* who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or
• •* who have sexual relationships with female partners only and/or with sterile male partners or
• •* who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception\*\* from the time of screening until end of the clinical trial.
• •* The following methods of contraception are acceptable): e.g.
• •* progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
• •* male or female condom with or without spermicide
• •* cap, diaphragm or sponge with spermicide