Study to investigate the improvement on morbitity and mortality and frequence of disease by intravenous iron therapy in patients with disturbance of heart function and iron deficiency

Phase 1

• Conditions: Systolic heart failure associated with iron deficiency; MedDRA version: 20.0Level: LLTClassification code 10074631Term: Systolic heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-000068-40-SI
• Lead Sponsor: niversity Medical Centre Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-26
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Patients with chronic HFrEF (CHF) of at least 3 months duration and a history of documented LVEF<45%.
2. Confirmed presence of ID (ferritin < 100 ng/mL or ferritin 100 – 299 ng/mL with TSAT < 20 %)
3. Serum haemoglobin of 9.5 - 14.0 g/dL
4. At time of screening considered re-stabilised and planned for discharge within next 24 h (NYHA 2 or 3), or stable ambulatory with a HF hospitalisation in the past 12 months (NYHA 2-4), or stable ambulatory with BNP > 100 pg/mL or NT-proBNP > 300 pg/mL or MRproANP > 120 pmol/L (NYHA 2-4)
5. Written informed consent
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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

1. Hypersensitivity to the active substance, to FCM or any of its excipients
2. Known serious hypersensitivity to other parenteral iron products
3. Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia
4. Evidence of iron overload or disturbances in the utilisation of iron
5. History of severe asthma with known FEV1 <50%
6. Acute bacterial infection
7. Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needs to be corrected first)
8. Use of renal replacement therapy
9. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 6 weeks prior to randomisation.
10. More than 500 meters in the initial 6-minutes walking-test Note: We aim to recruit at least half of the patients with an initial 6-minute walking-test below 375 meters

Study & Design

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