NCT01978028终止4 期
Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment
研究概览
简要总结
The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients with chronic heart failure of New York Heart Association Class II or III, a left ventricular ejection fraction of ≤ 40% for patients in NYHA class II or ≤ 45% for patients in NYHA class III, a hemoglobin level at the screening visit between 9.5-13.5 g/dl, and iron deficiency, which is defined as serum ferritin level < 100µg/l or between 100 and 299 µg/l, when transferring saturation is < 20%.
- •Age ≥18 years
- •Obtained informed consent
- •Stable pharmacological therapy during the last 4 weeks (with the exception of diuretics)
排除标准
- •Hemochromatosis, iron overload, defined as TSAT > 45%
- •Known hypersensitivity to Ferinject®.
- •Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy.
- •Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.
- •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 ischemic 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.
- •Participation in a CHF training program.
- •Known HIV/AIDS.
- •Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
- •Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy).
- •Pregnancy or lactation.
- •Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
- •Anticoagulation
研究组 & 干预措施
ferric carboxymaltose
Active Comparator
ferric carboxymaltose
干预措施: ferric carboxymaltose (Drug)
placebo
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment
时间窗: 12 weeks
The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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