Oral iron supplementation with ferric maltol in patients with Pulmonary Hypertensio
- Conditions
- Patients with iron deficiency anemia and pulmonary hypertensionMedDRA version: 20.0Level: HLTClassification code 10037401Term: Pulmonary hypertensionsSystem Organ Class: 100000004855MedDRA version: 20.0Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-005100-26-DE
- Lead Sponsor
- Hannover Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
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 with a diagnosis of PH confirmed by a (historical) right heart catheterization showing a mean pulmonary artery pressure =25 mmHg at rest and stable PH medication for at least 3 months.
5. 6 min walk distance >50 m
6. 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
7. Prevention of pregnancy:
Women without childbearing potential defined as follows:
• at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
• hysterectomy or uterine agenesis or
• = 50 years and in postmenopausal state = 1 year or
• < 50 years and in postmenopausal state = 1 year with serum FSH > 40 IU/l and serum oestrogen < 30 ng/l or a negative oestrogen test
or
Women of childbearing potential with a negative ß-HCG pregnancy test at screening who agree to meet one of the following criteria from the time of screening, during the study and for a period of four weeks following the last administration of study medication:
• correct use of contraception methods. The following are acceptable: hormonal contraceptives (combined oral contraceptives and oestrogen-free pills with desogestrel, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUS) or a barrier method, e.g. condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam, gel, film, cream or suppository)
• true abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception)
• sexual relationship only with female partners and/or sterile male partners
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
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 (glomerular filtration rate <30 ml/min)
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. Hemoglobin <7 g/dl in females or <8 g/dl in males at screening
10. Concomitant erythropoietin medication
11. Pregnancy or lactation period
12. Subject has received any investigational medication or any investigational device 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 an investigational drug/devices during the course of the study.
13. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
14. Known haemochromatosis or other iron overload syndromes
15. Patients who have been receiving repeated (>1) blood transfusions during the past 6 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effects of oral ferric maltol on hemoglobin levels in patients with pulmonary hypertension and anemia caused by iron deficiency ;Secondary Objective: To assess the effects of oral ferric maltol on serum ferritin, transferrin saturation, 6 min walking distance, NT-proBNP, right ventricular function (determined by echocardiography) and World Health Organization Functional Class (WHO FC) in patients with pulmonary hypertension and anemia caused by iron deficiency;Primary end point(s): • Change in hemoglobin level from baseline to week 12;Timepoint(s) of evaluation of this end point: week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Change in hemoglobin from baseline to week 6<br>• Change in serum ferritin levels and transferrin saturation from baseline to week 6 and 12<br>• Change in 6 min walking distance from baseline to week 12 <br>• Change in serum NT-proBNP from baseline to weeks 6 and 12<br>• Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion) from baseline to week 12 in patients with pulmonary hypertension and anemia caused by iron deficiency.<br>• Change in WHO FC from baseline to week 6 and week 12<br>;Timepoint(s) of evaluation of this end point: week 6<br>week 6 and 12<br>week 12 <br>week 6 and 12<br>week 12<br>week 6 and 12