CKD5 Stage Dialysis, Heart Failure
Conditions
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.
Interventions
DRUGSacubitril/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).
DRUGIrbesartan
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.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed