Investigator-initiated, Randomized, Double-blind, Controlled, Multi-center Trial of Intravenous Iron in Patients With Cardiovascular Disease and Concomitant Iron Deficiency
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Cohort A: Left-ventricular ejection fraction
研究概览
简要总结
It is now recognized that iron deficiency in cardiovascular disease contributes to impaired clinical outcome.
详细描述
The clinical trial is designed as a prospective, multi-centre, double-blind, randomised, controlled, interventional trial to investigate whether a therapy with i.v. iron (iron carboxymaltose) compared to saline can improve functional status across a subset of cardiovascular disease -namely acute myocardial infarction, atrial fibrillation, and heart failure with reduced ejection fraction.
Iron administration will be carried out according to summary of product characteristics. Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg iron carboxymaltose (over 15 minutes), except when haemoglobin is > 16.0 g/dL or ferritin is > 600 µg/L.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort A (acute myocardial infarction): Acute Myocardial Infarction within 10 days (randomization/ first iron supplementation/ MRI must be performed within 10 days after AMI), without prior heart failure (defined as any known previous report of LVEF ≤ 45%) Cohort B (atrial fibrillation): Paroxysmal Atrial fibrillation or persistent AF Cohort C (heart failure): Left-ventricular ejection fraction ≤ 45 % (documented within the last 12 months prior to screening), all NYHA classes allowed
- •Confirmed presence of iron deficiency (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with transferrin saturation < 20 %)
- •Haemoglobin ≤ 15.5 g/dL
- •Written informed consent
排除标准
- •Evidence of iron overload or disturbances in the utilisation of iron
- •History of severe asthma, eczema or other atopic allergy
- •History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
- •Use of renal replacement therapy
- •Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 4 weeks prior to randomisation.
研究组 & 干预措施
Intravenous iron
Intravenous iron administration in the form of ferric carboxymaltose will be carried out according to summary of product characteristics. Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg ferric carboxymaltose at months 4 and 8, except when haemoglobin is > 16.0 g/dL or ferritin is > 600 µg/L. To avoid unblinding in these patients a saline infusion will be administered.
干预措施: Ferric carboxymaltose (Drug)
Placebo
Administration of i.v. NaCl according to the dosing rules for intravenous iron.
干预措施: Saline (Drug)
结局指标
主要结局
Cohort A: Left-ventricular ejection fraction
时间窗: 16 weeks
Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI
Cohort B: Burden of atrial fibrillation
时间窗: 12 months
Delta between treatment groups in burden of atrial fibrillation from day 90 to 365 as assessed by a routinely implanted event recorder.
Cohort C: Left-ventricular ejection fraction
时间窗: 16 weeks
Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI.
次要结局
未报告次要终点
研究者
Dr. med. Mahir Karakas
Coordinating Principal Investigator
Universitätsklinikum Hamburg-Eppendorf