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COMPLETEDPHASE4

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

A Pilot Study to Explore Safety, Tolerability and Efficacy of ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure

NCT05697211•Hannover Medical School

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+10 more 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
+9 more criteria

Locations (1)

Hannover Medical School, Department of Cardiology and Angiology

Hanover, Lower Saxony, Germany

Key Dates

Start Date

February 21, 2023

Primary Completion Date

January 8, 2025

Completion Date

January 8, 2025

Last Updated

March 7, 2025

Enrollment

ACTUAL participants

Conditions

Heart Failure, Left-sidedAnemia, Iron Deficiency

Interventions

Ferric maltol 30 mg (Feraccru®)

DRUG

IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department

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Anemia, Iron DeficiencyUterine Bleeding

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COMPLETEDPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department

Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease

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