ORal IrON supplementation with ferric maltol in patients with Heart Failure

Phase 1

• Conditions: Patients with heart failure, iron deficiency and anaemia with either reduced or preserved left ventricular ejection fraction; MedDRA version: 20.0Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: LLTClassification code 10024106Term: Left heart failureSystem Organ Class: 100000004849; MedDRA version: 20.1Level: LLTClassification code 10076396Term: Heart failure with preserved ejection fractionSystem Organ Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code 10078289Term: Heart failure with reduced ejection fractionSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-000130-33-DE
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-16
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Men, women*, inter/diverse aged = 18 at day of inclusion
2. Signed written informed consent from patient prior to any study-related procedure and
willingness to comply with treatment and follow-up procedures
3. Patients capable of understanding the investigational nature, potential risks and
benefits of the clinical trial
4. Patients with chronic heart failure with an LVEF<50% (HFrEF, HFmrEF) or patients
with chronic heart failure with an EF=50% (HFpEF) and New York Heart Association
functional class II-IV
5. 6 min walk distance >50 m
6. Mild-to-moderate anaemia and iron -deficiency as defined by a haemoglobin
concentration =8 g/dl and <12 g/dl in females or =9 g/dl and <13 g/dl in males, and
serum ferritin <100 µg/l, or 100-299 µg/l and transferrin saturation <20% at screening
7. *Women without childbearing potential defined as follows:
• females before menarche (if applicable)
• 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 estrogen < 30 ng/l or a negative estrogen test, both at screening
or
*Women of childbearing potential:
• who are practicing sexual abstinence (periodic abstinence and withdrawal are
not acceptable) or
• who have sexual relationships with female partners only and/or with sterile male partners or
• who are sexually active with fertile male partner, have a negative pregnancy
test during screening and agree to use reliable methods of contraception** from the time of screening until end of the clinical trial.
**The following methods of contraception are acceptable): e.g.
- progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
- male or female condom with or without spermicide
- cap, diaphragm or sponge with spermicide

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 40

Exclusion Criteria

1. Active haematological disorders other than anaemia and/or iron -deficiency
2. Other medical condition that according to the investigator’s assessment is causing or
contributing to anaemia
3. Active malignancy or currently receiving chemotherapy or radiotherapy
4. Active infectious disease
5. Active bleeding
6. Severe renal insufficiency (GFR < 20ml/min or 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. Concomitant therapy with Dimercaprol, Chloramphenicol and Methyldopa
11. ESA, i.v. iron or blood transfusion administered in last 3 months and oral iron (>100
mg/day) in previous 4 weeks
12. Pregnancy or lactation period
13. 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
14. Known or suspected hypersensitivity to any of the active substances or any
excipients of the investigational medicinal product
15. Known haemochromatosis or other iron overload syndromes
16. Patients with severe, uncorrected valvular heart disease
17. Clinical evidence of ACS, TIA or stroke within the last 30 days
18. CABG, PTCA, cardiac device implant/resynchronisation therapy or major surgery
leading to significant blood loss within last 30 days
19. Planned CABG, PTCA, cardiac device implant/resynchronisation therapy or major
surgery
20. Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects
with Vitamin B12 or folic acid deficiency who in the opinion of the Investigator are stable
and asymptomatic will be permitted.

Study & Design

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