NCT01394562已完成3 期
Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients With Iron Deficiency
Vifor Pharma1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2011年7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
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Change in Peak VO2 (mL/kg/min) from baseline to Week 24
研究概览
简要总结
The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.
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
- None
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
- •Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
- •Reduced exercise capacity
- •Reduced left ventricular ejection fraction
- •At least 18 years of age and with written informed consent prior to any study specific procedures
排除标准
- •Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation
- •Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
- •Chronic liver disease and/or elevated liver enzymes
- •Vitamin B12 and/or serum folate deficiency
- •Subject is not using adequate contraceptive precautions during the study
- •No other significant cardiac or general disorder that would compromise participation in the study
研究组 & 干预措施
Ferinject (ferric carboxymaltose)
Experimental
干预措施: Ferinject (ferric carboxymaltose) (Drug)
Standard of Care
Other
Standard of care. IV iron is not permitted
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in Peak VO2 (mL/kg/min) from baseline to Week 24
时间窗: Week 24
次要结局
未报告次要终点
研究者
研究点 (1)
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