This is an explorative, open-label, uncontrolled, single center study to explore the preliminary safety, tolerability and efficacy of oral ferric maltol in treating iron deficiency in patients with pulmonary hypertension and iron deficiency anemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
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
Hannover Medical School
Hanover, Germany
Change in hemoglobin level from baseline to week 12
measurement of hemoglobin in blood
Time frame: baseline to week 12
Change in hemoglobin from baseline to week 6
measurement of hemoglobin in blood
Time frame: baseline to week 6
Change in serum ferritin levels from baseline to week 6 and 12
measurement of serum ferritin levels
Time frame: baseline to week 6 and baseline to week 12
Change in transferrin saturation from baseline to week 6 and 12
measurement of transferrin saturation
Time frame: baseline to week 6 and baseline to week 12
Change in 6 min walking distance from baseline to week 12
measurement of functional exercise capacity
Time frame: baseline to week 12
Change in serum NT-proBNP from baseline to weeks 6 and 12
measurement of serum NT-proBNP
Time frame: baseline to week 6 and baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (1)
measurement of right atrial area
Time frame: from baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (2)
measurement of right ventricular diameter
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Time frame: from baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (3)
measurement of fractional area change
Time frame: from baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (4)
measurement of tricuspid annular plane systolic excursion
Time frame: from baseline to week 12
Change in World Health Organization Functional Class (WHO FC) from baseline to week 6 and week 12
measurement of different parameter according to an evaluated process
Time frame: from baseline to week 6 and week 12