Intravenous iron in patients with systolic heart failure and iron deficiency to improve morbidity & mortality

niversity Medical Centre Hamburg-Eppendorf0 个研究点目标入组 1,200 人开始时间: 2017年12月14日最近更新: 2024年7月29日

适应症

试验速览

暂无简介。

•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 to 14.0 g/dL
•4.At time of screening considered re-stabilized 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 MR-proANP > 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

•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 or chronic 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 randomization.
•10. More than 475 500 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

发起方

niversity Medical Centre Hamburg-Eppendorf