Status:
COMPLETED
Sacubitril/Valsartan for CKD5 Stage Dialysis Patients
Lead Sponsor:
Ruijin Hospital
Conditions:
CKD5 Stage Dialysis
Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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, r...
Eligibility Criteria
Inclusion
- CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
- NT-proBNP ≥2000pg/ml.
- hypertension
- Voluntary informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2023
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT05243199
Start Date
August 1 2020
End Date
March 8 2023
Last Update
March 17 2023
Active Locations (1)
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1
Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China