Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05243199
• Other study ID #: (2020)(137)
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: March 8, 2023

Study information

• Verified date: March 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: March 8, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• 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 (no follow-up exit criteria were found).
• Irbesartan
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.

Locations

Country	Name	City	State
China	Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The effect of ARNI on ambulatory blood pressure	The evaluation indicator include ambulatory blood pressure	1 year
Secondary	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
Secondary	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