ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices

• Status: Terminated
• Trial end date: 2019-11-29
• Target enrollment: 0
• Participant gender: All

Summary

This is a open-label, uncontrolled, monocenter, phase IV study. The aim of this study is to detect AEs or SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hannover Medical School
• Collaborator: Shields, Shields and Associates
• Treatments: Ferric Compounds; Ferric maltol

Criteria

Inclusion Criteria:

1. Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures

2. Male and female patients ≥18 years at day of inclusion

3. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial

4. Patients that have an LVAD implanted for chronic heart failure and which are clinically stable for at least 6 months after LVAD implantation in the opinion of the investigator

5. 6 min walk distance >50 m

6. Mild-to-moderate iron-deficiency anemia as defined by a hemoglobin concentration ≥7 g/dl and <12 g/dl in females or ≥8 g/dl and <13 g/dl in males, and serum ferritin <100 µg/l, or 100-300 µg/l and transferrin saturation <20% at screening

7. Women of childbearing potential must:

Have a negative pregnancy test at screening Agree to use reliable methods of contraception during the course of the study

Exclusion Criteria:

1. Active hematological disorders other than iron-deficiency anemia

2. Other medical condition that according to the investigator's assessment is causing or contributing to anemia

3. Active malignancy

4. Active infectious disease

5. Active bleeding

6. Severe renal insufficiency (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. Pregnancy or lactation period

11. 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.

12. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product

13. Known haemochromatosis or other iron overload syndromes

14. Patients who have been receiving repeated (>1) blood transfusions during the past 6 months