NCT01837082终止3 期
Randomized, Double-blind, Placebo-controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients With Congestive Heart Failure
University of Ulm3 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- The primary endpoint of the study is the change from baseline to week 12 in left-ventricular ejection fraction as determined by cardiac magnetic resonance imaging.
研究概览
简要总结
The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve left-ventricular ejection fraction in patients with heart failure and iron deficiency as determined by cardiac magnetic resonance imaging.
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
- •Congestive heart failure
- •At least 18 years of age
- •Iron deficiency
- •Dyspnea class II or III according to New York Heart Association
- •Left-ventricular ejection fraction ≤ 45%
排除标准
- •Known sensitivity to any of the products to be administered during dosing
- •Immediate need of transfusion
- •Patients presenting with an active infection
- •Thalassaemia
- •Other forms of microcytic anemia not caused by iron deficiency
- •History of acquired iron overload
- •Need for revascularization, ST-segment elevation myocardial infarction or Non-ST-segment elevation myocardial infarction during the past 3 months (at time of randomization)
- •Women who are pregnant or of childbearing age and not using medically acceptable effective contraception
研究组 & 干预措施
Iron
Active Comparator
ferric carboxymaltose
干预措施: ferric carboxymaltose (Drug)
Placebo
Placebo Comparator
Sodium chloride 0.9%
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint of the study is the change from baseline to week 12 in left-ventricular ejection fraction as determined by cardiac magnetic resonance imaging.
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Dr. Mahir Karakas
Dr. med.
University of Ulm
研究点 (3)
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