Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

Sacubitril/Valsartan for Dialysis Patients With CKD5 Stage Complicated With Hypertension- A Prospective, Randomized, Controlled Multicenter Study

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.

Inclusion Criteria:

• CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
• NT-proBNP ≥2000pg/ml.
• hypertension
• Voluntary informed consent.

Exclusion Criteria:

• 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.