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: 2016年9月12日最近更新: 2018年1月22日

适应症

试验速览

暂无简介。

•1.Patients with chronic HF (CHF) present for at least 12 months
•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, or stable ambulatory with a HF hospitalisation in the past 6 months, or stable ambulatory with BNP > 100 pg/mL or NT-proBNP > 300 pg/mL or MR-proANP > 120 pmol/L
•5.LVEF = 45 % (documented within the last 12 months prior to screening), NYHA class II or III
•6.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, eczema or other atopic allergy
•6.History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
•7.Acute or chronic infection
•8.Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needs to be corrected first)
•9.Use of renal replacement therapy
•10.Known allergy to FCM or its excipients
•11.Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 6 weeks prior to randomization.

发起方

niversity Medical Centre Hamburg-Eppendorf