NCT00821717终止3 期
A Randomised, Controlled, Observer-blinded Phase III Clinical Trial to Compare the Effect of Intravenous Ferric Carboxymaltose to Placebo on Exercise Capacity and Cardiac Function in Patients With Chronic Heart Failure and Iron Deficiency
Vifor Pharma1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2008年12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
- 35
- 试验地点
- 1
- 主要终点
- The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks
研究概览
简要总结
This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.
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
The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks
时间窗: 24 weeks
NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment
时间窗: 24 weeks
次要结局
- Cardiac function assessed by 2D Echo/Doppler cardiography(24 weeks)
- Self-reported patient global assessment of treatment(24 weeks)
- QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi(24 weeks)
研究者
研究点 (1)
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