Sacubitril/Valsartan for Dialysis Patients With CKD5 Stage Complicated With Hypertension- A Prospective, Randomized, Controlled Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- The effect of ARNI on blood pressure in patients with CKD who are on dialysis
研究概览
简要总结
Hemodialysis or peritoneal dialysis CKD5 patients were randomly divided into Sacubitril/Valsartan and irbesartan treatment groups. Comparing the blood pressure, survival rates, the cardiac function, renal function,and adverse reactions of two groups, to evaluate whether the efficacy and safety of Sacubitril/Valsartan in the treatment of patients with CKD dialysis combined with heart failure is superior to that of irbesartan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
- •NT-proBNP ≥2000pg/ml.
- •hypertension
- •Voluntary informed consent.
排除标准
- •Unable to tolerate ACEI/ARB class antihypertensive drugs;
- •History of symptomatic hypotension/systolic blood pressure <100mmHg at screening;
- •Potassium >6.0mmol/L;
- •History of angioedema;
- •Abnormal liver function such as ALT and/or AST >=3 times normal upper limit (ULN), total bilirubin >= 2 times ULN;
- •Moderate to severe anemia (hemoglobin <80g/L);
- •Cardiac surgery/intervention/cardiac resynchronization therapy has been performed in the past 3 months or is planned in the next 12 months;
- •Newly found malignant tumor (within 3 years), or undergoing radiotherapy/chemotherapy;
- •Pregnant and lactating women, or those of childbearing age who are unable to guarantee effective contraception;
- •New and serious life-threatening infections;
- •Active infectious diseases such as active tuberculosis, active viral hepatitis and HIV infection;
- •Persons suffering from mental disorders and taking psychotropic drugs;
- •Patients with life expectancy less than 12 months;
- •The doctor assessed that the patient was not easy to follow up or had poor compliance and was not suitable for enrollment;
- •Patients who do not want to sign informed consent.
研究组 & 干预措施
Sacubitril/Valsartan
The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it
干预措施: Sacubitril/Valsartan (Drug)
Irbesartan
the maximum tolerated dose of irbesartan was administered
干预措施: Irbesartan (Drug)
结局指标
主要结局
The effect of ARNI on blood pressure in patients with CKD who are on dialysis
时间窗: 1 year
The evaluation indicator include office blood pressure
次要结局
- The effect of ARNI on ambulatory blood pressure(1 year)
- The effect of ARNI on cardiac function in patients with CKD who are on dialysis(1 year)
- The safety of ARNI in patients with CKD who are on dialysis(1 year)
研究者
Nan Chen,MD
Principal Investigator,Director,Foreign academicians of the French National Academy of Medical Sciences,Director of institute of Nephrology affiliated to Shanghai Jiao Tong University Medical College
Ruijin Hospital