NCT00520780已完成3 期
A Randomised Double-blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Iron Carboxymaltose (Ferinject®) With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
Vifor Pharma5 个研究点 分布在 3 个国家目标入组 456 人开始时间: 2007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
- 已完成
- 发起方
- 入组人数
- 456
- 试验地点
- 5
- 主要终点
- Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy
研究概览
简要总结
This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.
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
- •In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF)
- •Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45% or lower in NYHA III
- •Screening haemoglobin (Hb) at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations)
- •Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%
排除标准
- •History of acquired iron overload.
- •Known active infection, clinically significant bleeding, active malignancy.
- •Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST)
- •Anaemia due to reasons other than iron deficiency
- •Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
- •History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
- •Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
- •Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months.
- •Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
研究组 & 干预措施
1
Experimental
干预措施: Ferinject ® (Ferric carboxymaltose) (Drug)
2
Placebo Comparator
干预措施: Normal saline (0.9%) (Drug)
结局指标
主要结局
Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy
时间窗: 24 weeks
次要结局
- Key secondary objectives (efficacy): Exercise tolerance (6-minute walk test distance). Further secondary objectives(efficacy): Health related quality of life, resource use and costs associated with the treatment, safety and tolerability(24 weeks)
研究者
研究点 (5)
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