Back to resultsORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices (ORION-LVAD-1)
Primary Purpose
Heart Failure, Left Sided, Anemia, Iron Deficiency
Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Ferric maltol 30 mg (Feraccru®)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Left Sided focused on measuring Iron Deficiency
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
- 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
Sites / Locations
- Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie (HTTG)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ferric maltol 30 mg (Feraccru®)
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in hemoglobin level from baseline to week 12
Change in hemoglobin level from baseline to week 6
Change in serum ferritin levels and transferrin saturation from baseline to week 6
Change in serum ferritin levels and transferrin saturation from baseline to week 12
Change in 6 min walking distance from baseline to week 12
Change in serum NT-proBNP from baseline to weeks 6
Change in serum NT-proBNP from 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 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)
Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12
Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6
Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12
Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6
Change in NYHA from baseline to week 12
Full Information
NCT ID
NCT03774615
First Posted
December 12, 2018
Last Updated
April 17, 2020
Sponsor
Hannover Medical School
Collaborators
Shields, Shields and Associates
1. Study Identification
Unique Protocol Identification Number
NCT03774615
Brief Title
ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices
Acronym
ORION-LVAD-1
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
November 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School
Collaborators
Shields, Shields and Associates
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Left Sided, Anemia, Iron Deficiency
Keywords
Iron Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
open-label, uncontrolled, monocenter, phase IV study
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferric maltol 30 mg (Feraccru®)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ferric maltol 30 mg (Feraccru®)
Intervention Description
Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change in hemoglobin level from baseline to week 12
Time Frame
baseline to week 12
Title
Change in hemoglobin level from baseline to week 6
Time Frame
baseline to week 6
Title
Change in serum ferritin levels and transferrin saturation from baseline to week 6
Time Frame
baseline to week 6
Title
Change in serum ferritin levels and transferrin saturation from baseline to week 12
Time Frame
baseline to week 12
Title
Change in 6 min walking distance from baseline to week 12
Time Frame
baseline to week 12
Title
Change in serum NT-proBNP from baseline to weeks 6
Time Frame
baseline to weeks 6
Title
Change in serum NT-proBNP from baseline to weeks 12
Time Frame
baseline to weeks 12
Title
Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion)
Time Frame
change from baseline to week 12
Title
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)
Time Frame
change from baseline to week 12
Title
Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12
Time Frame
from baseline to week 12
Title
Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6
Time Frame
from baseline to week 6
Title
Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12
Time Frame
from baseline to week 12
Title
Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6
Time Frame
from baseline to week 6
Title
Change in NYHA from baseline to week 12
Time Frame
from baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Schmitto, Prof. MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie (HTTG)
City
Hannover
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices
We'll reach out to this number within 24 hrs