A study to explore the safety of oral iron supplementation with ferric maltol in patients with heart failure carrying Left Ventricular Assist Devices

Phase 1

• Conditions: 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: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-005101-39-DE
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-15
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 25

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 <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 (IUD), intrauterine system (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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified