Status:
TERMINATED
ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Shields, Shields and Associates
Conditions:
Heart Failure, Left Sided
Anemia, Iron Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
- Male and female patients ≥18 years at day of inclusion
- Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
- 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
- 6 min walk distance \>50 m
- 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
- 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
- Active hematological disorders other than iron-deficiency anemia
- Other medical condition that according to the investigator's assessment is causing or contributing to anemia
- Active malignancy
- Active infectious disease
- Active bleeding
- Severe renal insufficiency (requiring dialysis)
- Severe liver injury as indicated by serum aminotransferases \>3 x upper limit of normal or bilirubin levels \>50 µmol/l
- Ongoing oral or intravenous iron supplementation
- Concomitant erythropoietin medication
- Pregnancy or lactation period
- 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.
- Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
- Known haemochromatosis or other iron overload syndromes
- Patients who have been receiving repeated (\>1) blood transfusions during the past 6 months
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03774615
Start Date
March 18 2019
End Date
November 29 2019
Last Update
April 21 2020
Active Locations (1)
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1
Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie (HTTG)
Hanover, Germany, 30625