A Pilot Study to Explore Safety, Tolerability and Efficacy of ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure

Hannover Medical School1 site in 1 country50 target enrollmentFebruary 21, 2023

ConditionsHeart Failure, Left-sided Anemia, Iron Deficiency

InterventionsFerric maltol 30 mg (Feraccru®)

Overview

Phase: Phase 4
Intervention: Ferric maltol 30 mg (Feraccru®)
Conditions: Heart Failure, Left-sided
Sponsor: Hannover Medical School
Enrollment: 50
Locations: 1
Primary Endpoint: Change in haemoglobin level from baseline to week 16
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 21, 2023

End Date

January 8, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hannover Medical School

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men, women\*, inter/diverse aged ≥ 18 at day of inclusion
•Signed written informed consent from patient prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
•Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
•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
•6 min walk distance \>50 m
•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
•\*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

Exclusion Criteria

•Active haematological disorders other than anaemia and/or iron -deficiency
•Other medical condition that according to the investigator's assessment is causing or contributing to anaemia
•Active malignancy or currently receiving chemotherapy or radiotherapy
•Active infectious disease
•Active bleeding
•Severe renal insufficiency (glomerular filtration rate (GFR) \< 20ml/min or requiring dialysis)
•Severe liver injury as indicated by serum aminotransferases \>3 x upper limit of normal or bilirubin levels \>50 µmol/l
•Ongoing oral or intravenous iron supplementation
•Concomitant erythropoietin medication
•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

Arms & Interventions

Feraccru® 30 mg hard capsules

Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily p.o., morning and evening, on an empty stomach

Intervention: Ferric maltol 30 mg (Feraccru®)

Outcomes

Primary Outcomes

Change in haemoglobin level from baseline to week 16

Time Frame: baseline to week 16

Secondary Outcomes

Change in echocardiographic marker of left ventricular function 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)
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)
Kidney: Change in Creatinine (+Glomerular filtration rate) from baseline to week 16(baseline to week 16)
Change in transferrin saturation from baseline to week 16(baseline to week 16)
Change in serum ferritin 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)
Change in echocardiographic markers of left ventricular function 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 serum N-terminal pro brain natriuretic peptide (NT-proBNP) from baseline to week 16(baseline to week 16)
Liver: Change in Albumin 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)