EUCTR2015-005744-34-DE进行中（未招募）1 期
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:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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)
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