Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

Phase 4

Completed

• Conditions: CKD5 Stage Dialysis; Heart Failure
• Interventions: Drug: Irbesartan; Drug: Sacubitril/Valsartan

• Registration Number: NCT05243199
• Lead Sponsor: Ruijin Hospital

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, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-16
• Status Verified: 2023-03
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-08
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irbesartan	Irbesartan	the maximum tolerated dose of irbesartan was administered
Sacubitril/Valsartan	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

Primary Outcome Measures

Name	Time	Method
The effect of ARNI on blood pressure in patients with CKD who are on dialysis	1 year	The evaluation indicator include office blood pressure

Secondary Outcome Measures

Name	Time	Method
The effect of ARNI on ambulatory blood pressure	1 year	The evaluation indicator include ambulatory blood pressure
The effect of ARNI on cardiac function in patients with CKD who are on dialysis	1 year	The evaluation indicators include heart function-related indicators such as NT pro-BNP and EF value
The safety of ARNI in patients with CKD who are on dialysis	1 year	The evaluation indicators incidence of death (including death from cardiovascular events or other causes), hyperkalemia and other adverse events.

Trial Locations

Locations (1)

Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China