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CompletedNCT05697211Updated Mar 7, 2025

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

A Phase 4 interventional study of Ferric maltol 30 mg (Feraccru®) in Heart Failure, Left-sided and Anemia, Iron Deficiency, sponsored by Hannover Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by Hannover Medical School · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure, Left-sided
  • Anemia, Iron Deficiency

Keywords

  • Iron Deficiency
03

In context

Heart Failure

5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's enrollment of 50 is below the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Hannover Medical School is the lead sponsor of 198 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria

Exclusion Criteria:

  1. Active haematological disorders other than anaemia and/or iron -deficiency
  2. Other medical condition that according to the investigator's assessment is causing or contributing to anaemia
  3. Active malignancy or currently receiving chemotherapy or radiotherapy
  4. Active infectious disease
  5. Active bleeding
  6. Severe renal insufficiency (glomerular filtration rate (GFR) \< 20ml/min or requiring dialysis)
  7. Severe liver injury as indicated by serum aminotransferases >3 x upper limit of normal or bilirubin levels >50 µmol/l
  8. Ongoing oral or intravenous iron supplementation
  9. Concomitant erythropoietin medication
  10. Erythropoiesis stimulating agents (ESA), i.v. iron or blood transfusion administered in last 3 months and oral iron (>100 mg/day) in previous 4 weeks
  11. Pregnancy or lactation period
  12. Subject has received any investigational medication or any investigational devices within 30 days prior to the first dose of study medication or is actively participating in any investigational drug/ devices trial, or is scheduled to receive investigational drug/devices during the course of the study
  13. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
  14. Known haemochromatosis or other iron overload syndromes
  15. Patients with severe, uncorrected valvular heart disease
  16. Clinical evidence of Acute coronary syndrome (ACS), Transient ischaemic attack (TIA) or stroke within the last 30 days
  17. Coronary artery bypass graft (CABG), Percutaneous transluminal coronary angioplasty (PTCA), cardiac device implant/resynchronisation therapy or major surgery leading to significant blood loss within last 30 days
  18. Planned CABG, PTCA, cardiac device implant/resynchronisation therapy or major surgery
  19. Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects with Vitamin B12 or folic acid deficiency who in the opinion of the Investigator are stable and asymptomatic will be permitted.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Feraccru® 30 mg hard capsules

    Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily p.o., morning and evening, on an empty stomach

    Drug: Ferric maltol 30 mg (Feraccru®)

Interventions

  • DrugFerric maltol 30 mg (Feraccru®)

    In this trial Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects.

06

What researchers measure

Primary outcomes

  1. Change in haemoglobin level from baseline to week 16

    Time frame: baseline to week 16

Secondary outcomes

  1. Change in serum ferritin from baseline to week 16

    Time frame: baseline to week 16

  2. Change in transferrin saturation from baseline to week 16

    Time frame: baseline to week 16

  3. Change in soluble transferrin receptor 1 from baseline to week 16

    Time frame: baseline to week 16

  4. Change in 6 min walking distance from baseline to week 16

    Time frame: baseline to week 16

  5. Change in Health-related quality of life (HRQoL, measured by KCCQ-12) from baseline to week 16

    KCCQ = Kansas City Cardiomyopathy Questionnaire The KCCQ 12 is a health-related quality of life questionnaire to measure the disease-specific health status of patients with heart failure. It is a 12 item questionnaire that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge and quality of life. Scores are generated for each domain and scaled from 0 to 100, with 0 denoting the lowest reportable health status and 100 the highest reportable health status.

    Time frame: baseline to week 16

  6. Change in serum N-terminal pro brain natriuretic peptide (NT-proBNP) from baseline to week 16

    Time frame: baseline to week 16

  7. Change in echocardiographic markers of left ventricular function from baseline to week 16

    measurement of left ventricular ejection fraction

    Time frame: baseline to week 16

  8. Change in echocardiographic markers of left ventricular function from baseline to week 16

    measurement of left ventricular diameter

    Time frame: baseline to week 16

  9. Change in echocardiographic markers of left ventricular function from baseline to week 16

    measurement of left ventricular end-systolic volume index

    Time frame: baseline to week 16

  10. Change in echocardiographic markers of left ventricular function from baseline to week 16

    measurement of left ventricular end-diastolic volume index

    Time frame: baseline to week 16

  11. Change in echocardiographic markers of left ventricular function from baseline to week 16

    measurement of left ventricular wall thickness

    Time frame: baseline to week 16

  12. Change in echocardiographic markers of left ventricular function from baseline to week 16

    measurement of left atrial volume index

    Time frame: baseline to week 16

  13. Change in echocardiographic markers of left ventricular function from baseline to week 16

    measurement of global longitudinal strain

    Time frame: baseline to week 16

  14. Change in echocardiographic marker of left ventricular function from baseline to week 16

    measurement of marker of diastolic function (E/e')

    Time frame: baseline to week 16

  15. Change in echocardiographic markers of right ventricular function from baseline to week 16

    measurement of right ventricular diameter

    Time frame: baseline to week 16

  16. Change in echocardiographic markers of right ventricular function from baseline to week 16

    measurement of tricuspid annular plane systolic excursion

    Time frame: baseline to week 16

  17. Change in echocardiographic markers of right ventricular function from baseline to week 16

    measurement of estimated systolic pulmonary arterial pressure

    Time frame: baseline to week 16

  18. Liver: Change in Albumin from baseline to week 16

    Time frame: baseline to week 16

  19. Liver: Change in Alanine transaminase (ALT) from baseline to week 16

    Time frame: baseline to week 16

  20. Liver: Change in Aspartate transaminase (AST) from baseline to week 16

    Time frame: baseline to week 16

  21. Liver: Change in Bilirubin from baseline to week 16

    Time frame: baseline to week 16

  22. Kidney: Change in Creatinine (+Glomerular filtration rate) from baseline to week 16

    Time frame: baseline to week 16

  23. Change in New York Heart Association (NYHA) class from baseline to week 16

    Time frame: baseline to week 16

Other outcomes

  1. Incidence of treatment-emergent adverse events (AEs)

    To assess the safety and tolerability of oral ferric maltol in heart failure patients with iron deficiency and anaemia.

    Time frame: up to Week 20

  2. Incidence of Adverse Events

    Number of drop-outs due to AEs

    Time frame: up to Week 20

07

Study locations

1 site
  • Hannover Medical School, Department of Cardiology and Angiology
    Hannover, Lower Saxony 30625, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05697211
Lead sponsor
Hannover Medical School
Collaborators
Norgine
Responsible party
Sponsor
First posted
Jan 25, 2023
Start date
Feb 21, 2023
Primary completion
Jan 8, 2025
Completion
Jan 8, 2025
Last update
Mar 7, 2025

Study contacts

Johann Bauersachs, Prof. Dr.
principal investigator · Hannover Medical School, Department of Cardiology and Angiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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