EUCTR2005-005278-59-PT进行中（未招募）不适用
A Double-blind, Randomized, Placebo-controlled, Multicenter Study toAssess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality andMorbidity in Heart Failure (HF) Subjects with Symptomatic Left VentricularSystolic 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 3,400 人开始时间: 2006年6月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,400
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
- 性别
- All
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 for = 3 months, and of NYHA class II, III or IV at the time of randomization. Subjects who are NYHA class II must have had an unplanned hospital admission or emergency room visit for a cardiovascular reason within 12 months prior to randomization.
- •Left ventricular ejection fraction = 35% by echocardiogram, radionuclide ventriculography, cardiac magnetic resonance imaging, or X-ray contrast ventriculography within 6 months prior to randomization (most recent available LVEF result determines eligibility). For patients with CRT, LVEF assessment for eligibility must be performed 6 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 > 3.5 mg/dL (> 310 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 cardiac defibrillator (ICD) within 30 days prior to randomization or initiation of cardiac resynchronization therapy (CRT with/without ICD) within 6 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: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with expected life expectancy of > 3 years).
- •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 informed consent or to comply with study procedures.
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