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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
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
Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie (HTTG)
Hanover, Germany
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
Change in hemoglobin level from baseline to week 12
Time frame: baseline to week 12
Change in hemoglobin level from baseline to week 6
Time frame: baseline to week 6
Change in serum ferritin levels and transferrin saturation from baseline to week 6
Time frame: baseline to week 6
Change in serum ferritin levels and transferrin saturation from baseline to week 12
Time frame: baseline to week 12
Change in 6 min walking distance from baseline to week 12
Time frame: baseline to week 12
Change in serum NT-proBNP from baseline to weeks 6
Time frame: baseline to weeks 6
Change in serum NT-proBNP from baseline to weeks 12
Time frame: 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)
Time frame: change from baseline to week 12
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)
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Time frame: change from baseline to week 12
Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12
Time frame: from baseline to week 12
Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6
Time frame: from baseline to week 6
Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12
Time frame: from baseline to week 12
Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6
Time frame: from baseline to week 6
Change in NYHA from baseline to week 12
Time frame: from baseline to week 12