Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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CKD5 Stage Dialysis, Heart Failure

Intervention / Treatment
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* Drug: Sacubitril/Valsartan
* Drug: Irbesartan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sacubitril/Valsartan<br>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 | Drug: Sacubitril/Valsartan<br>* 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 (no follow-up exit criteria were found).<br>* Other names: ARNI;|
| Active Comparator: Irbesartan<br>the maximum tolerated dose of irbesartan was administered | Drug: Irbesartan<br>* The Initial dose of 75 mg Qd with sand, such as patients can tolerate and follow-up exit criteria (not appear, to 75 mg Bid to maintain after 1 week, 2 weeks can still be tolerance is raised to 150 mg Bid.<br>* Other names: ARB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of ARNI on blood pressure in patients with CKD who are on dialysis | The evaluation indicator include office blood pressure | 1 year | 

Secondary Outcome Measures

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