Patients with iron deficiency anemia and heart failure carrying left ventricular assist devices (LVAD) MedDRA version: 20.0 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851 MedDRA version: 20.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 10
Conditions
Interventions
Trade Name: Feraccru® 30 mg Hartkapseln
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FERRIC MALTOL
CAS Number: 33725-54-1
Oth
Sponsors
Hannover Medical School
Eligibility
Sex/Gender
All
Inclusion 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 40 IU/l and serum oestrogen =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: To assess the effects of oral ferric maltol on hemoglobin levels in LVAD patients with iron deficiency anemia To assess the effects of oral ferric maltol on hemoglobin level, serum ferritin, transferrin saturation, 6 min walking distance, serum NT-proBNP, right and left ventricular function (determined by echocardiography), liver and renal function and NYHA class in LVAD patients with iron deficiency anemia ;Primary end point(s): Relative and absolute frequency of AEs and SAEs;Timepoint(s) of evaluation of this end point: from baseline Day 0 to week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 and 12 Change in 6 min walking distance from baseline to week 12 Change in serum NT-proBNP from baseline to weeks 6 and 12 Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion) and 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. • Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6 and 12 • Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6 and 12 • Change in NYHA from baseline to week 12 ; Timepoint(s) of evaluation of this end point: Week 12 Week 6 Week 6 and 12 Week 12 Weeks 6 and 12 Week 12 Week 6 and 12 Week 6 and 12 Week 12 | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Jan. D. Schmitto
Medizinische Hochschule Hannover
Outcome results
None listed