Randomized, Double-Blinded, Controlled Trial of Intravenous Iron in Patients With Cardiovascular Disease and Concomitant Iron Deficiency

niversity Medical Centre Hamburg-Eppendorf0 个研究点目标入组 240 人开始时间: 2018年9月28日最近更新: 2022年1月4日

试验速览

暂无简介。

•1. Cohort A (AMI): Acute Myocardial Infarction within 10 days (randomization/ first iron supple-mentation/ MRI must be performed within 10 days after AMI), without prior heart failure (defined as any known previous report of LVEF = 45%)
•Cohort B (AF): Paroxysmal Atrial fibrillation or persistent AF
•Cohort C (HF): LVEF = 45 % (documented within the last 12 months prior to screening), all NYHA classes allowed
•2. Confirmed presence of ID (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT < 20 %)
•3. Haemoglobin = 15.5 g/dL
•4. Patients aged at least 18 years
•5. Provided written informed consent
•6. Females/Males who agree to comply with the applicable contraceptive requirements of the pro-tocol
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 140

•1. Evidence of iron overload or disturbances in the utilisation of iron
•2. History of severe asthma, eczema or other atopic allergy
•3. History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
•4. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 6 weeks prior to randomisation
•5. Oral iron therapy at doses > 100 mg/day at randomisation
•6. Current use of renal replacement therapy
•7. Patient at an immediate need of transfusion (hemoglobin below 7.5 g/dL or at the discretion of the investigator)

发起方

niversity Medical Centre Hamburg-Eppendorf