Clinical trial NCT03774615: ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices
Official title: A Phase IV Study to Explore the Safety of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Heart Failure Carrying Left Ventricular Assist Devices (ORION-LVAD-1)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure, Left Sided
Anemia, Iron Deficiency
Keywords: Iron Deficiency
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Shields, Shields and Associates
First posted: 2018-12-13
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label, uncontrolled, monocenter, phase IV study
Primary purpose: TREATMENT

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 treated with oral ferric maltol for 12 weeks.


Eligibility 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

Primary outcomes:
measure: To detect AEs and 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
timeFrame: baseline to week 12
Secondary outcomes:
measure: Change in hemoglobin level from baseline to week 12
timeFrame: baseline to week 12
measure: Change in hemoglobin level from baseline to week 6
timeFrame: baseline to week 6
measure: Change in serum ferritin levels and transferrin saturation from baseline to week 6
timeFrame: baseline to week 6
measure: Change in serum ferritin levels and transferrin saturation from baseline to week 12
timeFrame: baseline to week 12
measure: Change in 6 min walking distance from baseline to week 12
timeFrame: baseline to week 12
measure: Change in serum NT-proBNP from baseline to weeks 6
timeFrame: baseline to weeks 6
measure: Change in serum NT-proBNP from baseline to weeks 12
timeFrame: baseline to weeks 12
measure: Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion)
timeFrame: change from baseline to week 12
measure: Change in echocardiographic markers of left ventricular function (left ventricular ejection fraction, left atrial area, left ventricular diameter, fractional area change, tricuspid annular plane systolic excursion)
timeFrame: change from baseline to week 12
measure: Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12
timeFrame: from baseline to week 12
measure: Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6
timeFrame: from baseline to week 6
measure: Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12
timeFrame: from baseline to week 12
measure: Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6
timeFrame: from baseline to week 6
measure: Change in NYHA from baseline to week 12
timeFrame: from baseline to week 12
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie (HTTG)
Study officials:
affiliation: Hannover Medical School
name: Jan Schmitto, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: