Effect of erythropoietin stimulating agent on endothelial function in non-dialysis chronic kidney disease patients
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 13
研究概览
简要总结
Background: This study investigated whether administering erythropoiesis-stimulating agents (ESAs) improves endothelial function in patients with non-dialysis chronic kidney disease (CKD) and anemia. Methods: This single-center, prospective, single-arm comparison study enrolled patients with non-dialysis CKD (stages 4-5) and hemoglobin levels <10g/dL. ESA administration followed the Kidney Disease: Improving Global Outcomes guideline. The primary endpoint was the change in flow-mediated dilatation after ESA administration in individual patients. The secondary endpoints were changes in 6-minute walk test results, blood pressure, New York Heart Association class, and echocardiographic parameters. The echocardiographic parameters examined included chamber quantification, Doppler parameters, and systolic and diastolic function parameters. Results: Initially, 13 patients were screened, but 2 discontinued due to either heart failure or voluntary withdrawal. The mean flowmediated dilatation values significantly increased by 10.59% (from 1.36%±1.91% to 11.95%±8.11%, P=.001). Echocardiographic findings showed that the left ventricular mass index decreased by 11.9g/m2 (from 105.8±16.3 to 93.9±19.5g/m2, P=.006), and the left atrial volume index decreased by 10.8mL/m2 (from 50.1±11.3 to 39.3±11.3mL/m2, P=.004) after 12weeks of ESA administration. There were no significant differences between pre- and post-ESA treatment 6-minute walk test results. No significant side effects were observed during the study period. Conclusions: This is the first clinical study to demonstrate that an ESA improves endothelial dysfunction, left ventricular hypertrophy, and left atrial volume in patients with non-dialysis CKD. Thus, ESAs may be considered as adjunctive therapy for reducing cardiovascular risk in these patients.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •a person who has signed a written consent form of 10,000 to 20 years of age or older.
- •Patients with chronic kidney disease stage 4,5 (GFR 10-30 ml/min/1.73 m2) without dialysis
- •Blood colouring (Hb) < 10 mg/dL
- •Heart retraction function is normal (LVEF > 55%)
排除标准
- •a history of erythropoietin administration within the last three months.
- •A person who is subject to or needs to perform dialysis.
- •Uncontrolled hypertension
- •an expected life expectancy of less than one year
- •Someone who needs surgery for meaningful valve disease
- •Any person who has evidence of acute coronary syndrome within 60 days;
- •Patients with heart failure due to acute myocarditis, limited myocardial infarction and deadlocked myocardial infarction
- •Anemia with severe bleeding (Hb < 7 mg/dL)
- •Persons with other diseases (e.g. chronic closed lung disease)
- •Heart failure patients with meaningful arrhythmia (VCD, V-V-V, V-V-V-V-V-V-V-V-V-V-V-V-P)
- •Total bilirubin > 3 mg/dL, albumin < 2.8 mg/dL)
- •Pregnant women, nursing mothers
- •Persons currently participating in other clinical trials