ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients … (NCT05697211) | Clinical Trial Compass
CompletedPhase 4
ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure (ORION-HF)
Germany50 participantsStarted 2023-02-21
Plain-language summary
This is an open-label, single arm, multicenter pilot-study to explore the safety, tolerability and efficacy of oral iron supplementation with ferric maltol in treating iron deficiency and anaemia in patients with heart failure.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men, women\*, inter/diverse aged ≥ 18 at day of inclusion
✓. Signed written informed consent from patient prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
✓. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
✓. 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
✓. 6 min walk distance \>50 m
✓. 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
✓. \*Women without childbearing potential defined as follows:
Exclusion criteria
✕. Active haematological disorders other than anaemia and/or iron -deficiency
✕. Other medical condition that according to the investigator's assessment is causing or contributing to anaemia
✕. Active malignancy or currently receiving chemotherapy or radiotherapy
✕
What they're measuring
1
Change in haemoglobin level from baseline to week 16