Anemia, Iron Deficiency, Heart Failure, Left-sided
Conditions
Keywords
Iron Deficiency
Brief summary
This is an open-label, single arm, multicenter pilot-study to explore the safety, tolerability and efficacy of oral iron supplementation with ferric maltol in treating iron deficiency and anaemia in patients with heart failure.
Interventions
In this trial 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.
Sponsors
Norgine
Hannover Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Left ventricular ejection fraction (LVEF)\<50% (Heart failure with reduced ejection fraction (HFrEF), Heart failure with a mid-range ejection fraction (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 Follicle stimulating hormone (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
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 (glomerular filtration rate (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. Erythropoiesis stimulating agents (ESA), i.v. iron or blood transfusion administered in last 3 months and oral iron (\>100 mg/day) in previous 4 weeks 11. Pregnancy or lactation period 12. 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 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 with severe, uncorrected valvular heart disease 16. Clinical evidence of Acute coronary syndrome (ACS), Transient ischaemic attack (TIA) or stroke within the last 30 days 17. Coronary artery bypass graft (CABG), Percutaneous transluminal coronary angioplasty (PTCA), cardiac device implant/resynchronisation therapy or major surgery leading to significant blood loss within last 30 days 18. Planned CABG, PTCA, cardiac device implant/resynchronisation therapy or major surgery 19. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in haemoglobin level from baseline to week 16 | baseline to week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum ferritin from baseline to week 16 | baseline to week 16 | — |
| Change in transferrin saturation from baseline to week 16 | baseline to week 16 | — |
| Change in soluble transferrin receptor 1 from baseline to week 16 | baseline to week 16 | — |
| Change in 6 min walking distance from baseline to week 16 | baseline to week 16 | — |
| Change in Health-related quality of life (HRQoL, measured by KCCQ-12) from baseline to week 16 | baseline to week 16 | KCCQ = Kansas City Cardiomyopathy Questionnaire The KCCQ 12 is a health-related quality of life questionnaire to measure the disease-specific health status of patients with heart failure. It is a 12 item questionnaire that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge and quality of life. Scores are generated for each domain and scaled from 0 to 100, with 0 denoting the lowest reportable health status and 100 the highest reportable health status. |
| Change in serum N-terminal pro brain natriuretic peptide (NT-proBNP) from baseline to week 16 | baseline to week 16 | — |
| Change in echocardiographic markers of left ventricular function from baseline to week 16 | baseline to week 16 | measurement of left ventricular ejection fraction |
| Change in echocardiographic marker of left ventricular function from baseline to week 16 | baseline to week 16 | measurement of marker of diastolic function (E/e') |
| Kidney: Change in Creatinine (+Glomerular filtration rate) from baseline to week 16 | baseline to week 16 | — |
| Change in New York Heart Association (NYHA) class from baseline to week 16 | baseline to week 16 | — |
| Change in echocardiographic markers of right ventricular function from baseline to week 16 | baseline to week 16 | measurement of right ventricular diameter |
| Liver: Change in Albumin from baseline to week 16 | baseline to week 16 | — |
| Liver: Change in Alanine transaminase (ALT) from baseline to week 16 | baseline to week 16 | — |
| Liver: Change in Aspartate transaminase (AST) from baseline to week 16 | baseline to week 16 | — |
| Liver: Change in Bilirubin from baseline to week 16 | baseline to week 16 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (AEs) | up to Week 20 | To assess the safety and tolerability of oral ferric maltol in heart failure patients with iron deficiency and anaemia. |
| Incidence of Adverse Events | up to Week 20 | Number of drop-outs due to AEs |
Countries
Germany
Outcome results
None listed