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)

Hannover Medical School1 site in 1 country11 target enrollmentMarch 18, 2019

ConditionsHeart Failure, Left Sided Anemia, Iron Deficiency

InterventionsFerric maltol 30 mg (Feraccru®)

DrugsFerric maltol 30 mg (Feraccru®)

Overview

Phase: Phase 4
Intervention: Ferric maltol 30 mg (Feraccru®)
Conditions: Heart Failure, Left Sided
Sponsor: Hannover Medical School
Enrollment: 11
Locations: 1
Primary Endpoint: 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
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 18, 2019

End Date

November 29, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hannover Medical School

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Arms & Interventions

Ferric maltol 30 mg (Feraccru®)

Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily, morning and evening, on an empty stomach for 12 weeks

Intervention: Ferric maltol 30 mg (Feraccru®)

Outcomes

Primary Outcomes

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

Time Frame: baseline to week 12

Secondary Outcomes

Change in NYHA from baseline to week 12(from baseline to week 12)
Change in serum ferritin levels and transferrin saturation from baseline to week 6(baseline to week 6)
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)(change from baseline to week 12)
Change in hemoglobin level from baseline to week 12(baseline to week 12)
Change in 6 min walking distance from baseline to week 12(baseline to week 12)
Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12(from baseline to week 12)
Change in hemoglobin level from baseline to week 6(baseline to week 6)
Change in serum ferritin levels and transferrin saturation from baseline to week 12(baseline to week 12)
Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12(from baseline to week 12)
Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6(from baseline to week 6)
Change in serum NT-proBNP from baseline to weeks 6(baseline to weeks 6)
Change in serum NT-proBNP from baseline to weeks 12(baseline to weeks 12)
Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion)(change from baseline to week 12)
Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6(from baseline to week 6)