The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- cardiovascular events (heart failure, myocardial infarction, unstable angina which need hospitalization，heart surgery, or death caused by cardiovascular disease.)
研究概览
简要总结
The purpose of this study is to determine whether Febuxostat could protect cardiovascular function of peritoneal dialysis patients by lowering serum uric acid.
详细描述
Patients with more than 3-month-history of peritoneal dialysis and hyperuricemia. Use Febuxostat to control their serum uric acid for 1 year. To observe the cardiovascular events of patients, and compare and evaluate the changes of heart function, heart construction, serum cardiac markers and brain natriuretic peptide (BNP) levels before and after Febuxostat treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peritoneal dialysis for more than 3 months with hyperuricemia.
排除标准
- •Acute hepatopathy or liver dysfunction (Aspartate transaminase and/or alanine aminotransferase exceed 2 times of normal range)
- •Heart failure (stage IV, NYHA), unstable angina, acute stroke
- •Severe lung disease or cancer
- •unable to sign the informed consent form or disagree following-up.
结局指标
主要结局
cardiovascular events (heart failure, myocardial infarction, unstable angina which need hospitalization，heart surgery, or death caused by cardiovascular disease.)
时间窗: 1 year
heart failure, myocardial infarction, unstable angina which need hospitalization，heart surgery, or death caused by cardiovascular disease.
次要结局
- Serum uric acid(1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month)
- cardiovascular function (Heart construction and cardiac ejection fraction determined by echocardiography; blood test: cardiac markers including troponin,myoglobin and creatinine kinase, MB isoenzyme (CK-MB), brain natriuretic peptide)(6 months)
研究者
Ai Peng
Chief of department of Nephrology & Rheumatology
Shanghai 10th People's Hospital