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

Phase 4

Recruiting

• Conditions: Heart Failure, Left-sided; Anemia, Iron Deficiency

• Registration Number: NCT05697211
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-8-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Men, women*, inter/diverse aged = 18 at day of inclusion<br><br> 2. Signed written informed consent from patient prior to any study-related procedure<br> and willingness to comply with treatment and follow-up procedures<br><br> 3. Patients capable of understanding the investigational nature, potential risks and<br> benefits of the clinical trial<br><br> 4. Patients with chronic heart failure with an Left ventricular ejection fraction<br> (LVEF)<50% (Heart failure with reduced ejection fraction (HFrEF), Heart failure with<br> a mid-range ejection fraction (HFmrEF)) or patients with chronic heart failure with<br> an EF=50% (HFpEF) and New York Heart Association functional class II-IV<br><br> 5. 6 min walk distance >50 m<br><br> 6. Mild-to-moderate anaemia and iron -deficiency as defined by a haemoglobin<br> concentration =8 g/dl and <12 g/dl in females or =9 g/dl and <13 g/dl in males, and<br> serum ferritin <100 µg/l, or 100-299 µg/l and transferrin saturation <20% at<br> screening<br><br> 7. Women without childbearing potential defined as follows:<br><br> - females before menarche (if applicable)<br><br> - at least 6 weeks after surgical sterilization by bilateral tubal ligation or<br> bilateral oophorectomy or<br><br> - hysterectomy or uterine agenesis or<br><br> - = 50 years and in postmenopausal state > 1 year or<br><br> - < 50 years and in postmenopausal state > 1 year with serum Follicle stimulating<br> hormone (FSH) > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen<br> test, both at screening or<br><br> Women of childbearing potential:<br><br> - who are practicing sexual abstinence (periodic abstinence and withdrawal are<br> not acceptable) or<br><br> - who have sexual relationships with female partners only and/or with sterile<br> male partners or<br><br> - who are sexually active with fertile male partner, have a negative pregnancy<br> test during screening and agree to use reliable methods of contraception from<br> the time of screening until end of the clinical trial.<br><br> - The following methods of contraception are acceptable): e.g.<br><br> - progestogen-only oral hormonal contraception, where inhibition of<br> ovulation is not the primary mode of action<br><br> - male or female condom with or without spermicide<br><br> - cap, diaphragm or sponge with spermicide<br><br>Exclusion Criteria:<br><br> 1. Active haematological disorders other than anaemia and/or iron -deficiency<br><br> 2. Other medical condition that according to the investigator's assessment is causing<br> or contributing to anaemia<br><br> 3. Active malignancy or currently receiving chemotherapy or radiotherapy<br><br> 4. Active infectious disease<br><br> 5. Active bleeding<br><br> 6. Severe renal insufficiency (glomerular filtration rate (GFR) < 20ml/min or requiring<br> dialysis)<br><br> 7. Severe liver injury as indicated by serum aminotransferases >3 x upper limit of<br> normal or bilirubin levels >50 µmol/l<br><br> 8. Ongoing oral or intravenous iron supplementation<br><br> 9. Concomitant erythropoietin medication<br><br> 10. Erythropoiesis stimulating agents (ESA), i.v. iron or blood transfusion administered<br> in last 3 months and oral iron (>100 mg/day) in previous 4 weeks<br><br> 11. Pregnancy or lactation period<br><br> 12. Subject has received any investigational medication or any investigational devices<br> within 30 days prior to the first dose of study medication or is actively<br> participating in any investigational drug/ devices trial, or is scheduled to receive<br> investigational drug/devices during the course of the study<br><br> 13. Known or suspected hypersensitivity to any of the active substances or any<br> excipients of the investigational medicinal product<br><br> 14. Known haemochromatosis or other iron overload syndromes<br><br> 15. Patients with severe, uncorrected valvular heart disease<br><br> 16. Clinical evidence of Acute coronary syndrome (ACS), Transient ischaemic attack (TIA)<br> or stroke within the last 30 days<br><br> 17. Coronary artery bypass graft (CABG), Percutaneous transluminal coronary angioplasty<br> (PTCA), cardiac device implant/resynchronisation therapy or major surgery leading to<br> significant blood loss within last 30 days<br><br> 18. Planned CABG, PTCA, cardiac device implant/resynchronisation therapy or major<br> surgery<br><br> 19. Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy).<br> Subjects with Vitamin B12 or folic acid deficiency who in the opinion of the<br> Investigator are stable and asymptomatic will be permitted.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in haemoglobin level from baseline to week 16