Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

Shanghai Jiao Tong University

Status and phase

Completed

Phase 4

Conditions

CKD5 Stage Dialysis

Heart Failure

Treatments

Drug: Sacubitril/Valsartan

Drug: Irbesartan

Study type

Interventional

Funder types

Other

Identifiers

NCT05243199

(2020)(137)

Details and patient eligibility

About

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.

Enrollment

330 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.