NL-OMON33549尚未招募4 期
Myocardial perfusion and function in chronic heart failure patients treated with erythropoietin assessed by PET and MRI - REACH
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Male and female patients >= 18 years of age.
- •-Congestive heart failure, NYHA II-IV based on complaints of the patient at randomization, and a documented ejection fraction <45%, as determined by echocardiography, CMR or nuclear imaging within 6 months prior to randomization.
- •-Anemia (Hb < 10.0 g/dL [6.2 mmol/L]), and normal serum iron concentration (serum iron > 11 µmol/L ; ferritin < 14 µG/L).
- •-Patients should be clinically stable: for >= 3 months: no addition or deletion of any new drug(s) to treat heart failure (dose changes will be allowed); and no hospitalization for heart failure >= 3 months prior to randomization.
- •-Written, informed consent.
排除标准
- •-Known hypersensitivity to NeoRecormon or any of its components.
- •-Female patients of childbearing age not using an adequate method of contraception.
- •-Pregnancy.
- •-Participation in an Investigational Drug Trial in the last 6 months before randomization.
- •-Known non-CHF-related cause of anemia (additional internal medicine evaluation required, see later) including carcinoma, gastrointestinal bleeding focus, bone marrow dysfunction (for example anaplastic anemia), hypothyroidism, vitamin B12 deficiency, iron deficiency, folic acid depletion.
- •-Severe renal dysfunction, creatinin clearance < 30 ml/min (according to Cockroft-Gould formula) or serum creatinin > 220 mmol/L (possible or definite renal indication for exogenous EPO administration).
- •-Scheduled revascularization procedures (PTCA, CABG) or CRT (cardiac resynchronization therapy), known at trial entry.
- •-Any other foreseeable indication for surgery within the trial period.
- •-Severe COPD (FEV1<1.0 liter).
- •-Uncontrolled hypertension (>140/90 mmHg).
- •-Patients with a history of venous thrombo-embolic disease, including deep venous thrombosis and pulmonary embolism.
- •-CHF-patients not clinically stable, i.e. addition or deletion of any new drug(s) to treat heart failure (dose changes will be allowed) or hospitalization for heart failure >= 3 months prior to randomization.
- •-Patients with a myocardial infarction or cerebrovascular accident within 6 months before randomization.
- •-Contraindication for MRI (implant devices, claustrophobia)
- •-Curable malignancy
研究者
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