EUCTR2005-005278-59-GB进行中（未招募）1 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia. - RED-HF Trial – Reduction of Events with Darbepoetin alfa in Heart Failure Trial
Amgen Inc.0 个研究点目标入组 2,600 人开始时间: 2006年4月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Before any study-specific procedure, the appropriate written informed consent must be obtained.
- •= 18 years of age at the time of randomization.
- •Heart failure = 3 months, and of NYHA class II, III, and IV at the time of randomisation.
- •Left ventricular ejection fraction = 40% by echocardiogram, radionuclide ventriculography, cardiac magnetic resonance imaging, or X-ray contrast ventriculography within 6 months prior to randomization. For patients with CRT, LVEF assessment for eligibility must be performed at least 3 months after device implantation.
- •Hemoglobin concentration must be = 9.0 g/dL and = 12.0 g/dL (average of 2 hemoglobin concentrations as measured by blinded [coded] HemoCue® analyzer).
- •Treated for HF with stable, optimal pharmacological therapy. In general, optimal treatment will include a beta-blocker and an ACE inhibitor and/or an ARB at doses shown to be efficacious in HF trials, unless not tolerated. Stable medical therapy is defined as having no new HF drug class introduced 4 weeks prior to randomization, although doses of all drugs being received may be adjusted throughout the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Poorly controlled hypertension, defined as blood pressure > 160/100 mm Hg assessed on two separate occasions prior to randomization.
- •Serum creatinine > 3.0 mg/dL (> 265 µmol/L)
- •Heart failure primarily due to valvular heart disease or clinically significant valvular heart disease that might lead to surgical correction within 12 months of randomization.
- •Implantable cardioverter defibrillator (ICD) within 30 days prior to randomization or initiation of cardiac resynchronization therapy (CRT with/without ICD) within 3 months prior to randomization.
- •Routinely scheduled IV infusions for HF (eg, inotropes, vasodilators [eg, nesiritide], diuretics).
- •Acute myocardial infarction or cerebrovascular accident within 3 months prior to randomization.
- •Percutaneous intervention (cardiac, cerebrovascular, aortic) within 8 weeks prior to randomization. Major surgery, including thoracic or cardiac surgery, within 3 months prior to randomization.
- •Symptomatic tachyarrhythmia with an uncontrolled ventricular response (> 100 bpm at rest) or an untreated symptomatic bradyarrhythmia within 1 month prior to randomization.
- •Hypertrophic obstructive cardiomyopathy, active myocarditis, or constrictive pericarditis.
- •Likely to receive cardiac transplant within 12 months after randomization.
- •Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow) or receiving renal replacement therapy.
- •Anemia that is due to acute or chronic bleeding.
- •Transferrin saturation (Tsat) < 15% at the time of screening (value rounded to the nearest full percentage point).
- •Serum vitamin B12 or folate level below the lower limit of normal.
- •Whole blood or red blood cell (RBC) transfusion within 8 weeks prior to randomization.
- •Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years.
- •Receiving or has received chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months prior to randomization or clinical evidence of current malignancy, with the following exceptions: localized basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
- •Known active systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia), hemolysis due to any cause, thalassemia.
- •Untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease.
- •Use of any erythropoietic protein (eg, rHuEPO) within 12 weeks prior to randomization.
- •Known hypersensitivity to any of the products to be administered during the study, including oral or IV iron.
- •Subject is pregnant (eg, positive human chorionic gonadotropin [HCG] test), is breast feeding, or is of child-bearing potential and not using adequate contraceptive precautions.
- •Currently enrolled in, or at least 30 days not yet elapsed since ending participation in other investigational device or drug trial(s) or receiving other investigational agent(s) or procedure(s).
- •Subject has a disorder that compromises the ability of the subject to give written in
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