Hypertensive patients with CKD stage G4-to-G5 Hypertension, Chronic kidney disease
Conditions
Interventions
Administration of sacubitril/valsartan 100mg daily will be performed instead of ARB participants are using.
At 4 (+/-2) weeks after sacubitril/valsartan administration, the dose of sacubitril/valsart
C549068
sacubitril/valsartan
Sponsors
Kinguchi Sho
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (i) Aged >= 18 years of age on day of signing informed consent (male/female) (ii) CKD of G4-to-G5 categories (eGFR = 130 mmHg, or diastolic office blood pressure >= 80 mmHg (Systolic office blood pressure >= 140 mmHg, or diastolic office blood pressure >= 90 mmHg, if participants are 75 years of age or older without proteinuria (v) Written informed consent
Exclusion criteria
Exclusion criteria: (i) Bilateral renal artery stenosis, or renal artery stenosis in patients who have only one kidney. (ii) Patients who were pregnant, or breastfeeding women. (iii) Hyperkalemia (Serum potassium > 5.5 mEq/L) (iv) History of angioedema (v) Severe hepatic insufficiency and/or significant abnormal liver function (alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of the normal range, Child-Pugh category C) (vi) Hypersensitivity for sacubitril/valsartan. (vii) Current treatment with ACE inhibitors, or within 36 hours after ACE inhibitors discontinuance. (viii) Current treatment with aliskiren. (ix) Patients judged by the investigator to be ineligible for some other reason. (x) office, or home, systolic blood pressure >= 200mmHg (xi) Current treatment with maximum dose of ARBs (xii) History of acute coronary syndrome, or stroke within the past 3 months. (xiii) Patients under treatment with malignant tumor. (xiv) New York Heart Association class II to IV heart failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 24 hour mean systolic blood pressure measured by ABPM at 12 weeks after sacubitril/valsartan administration instead of ARB participants are using at enrollment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessments (increase in serum Cr >= 30%, incidence of hyperkalemia) Change in 24 hour mean diastolic blood pressure measured by ABPM at 12 weeks. Change in daytime mean systolic/diastolic blood pressure measured by ABPM at 12 weeks. Change in nocturnal mean systolic/diastolic blood pressure measured by ABPM at 12 weeks. Change in SD, and CV, of 24 hour, daytime, and nocturnal systolic/diastolic blood pressure measured by ABPM at 12 weeks. Change in percentages of dipper, and non-dipper. Change in mean moring home blood pressure, and home blood pressure variability (SD). Change in office blood pressures. Percentages of achievement of target office, or home, blood pressure levels. Change in pulse rate, body weight, and body mass index. Change in the following items. Blood analysis Hematology Alb, AST, ALT, BUN, Cr, eGFR, UA, Na, K, Cl, Ca, P NT-proBNP PRA, PAC LDL-cholesterol, HDL-cholesterol, triglyceride Urine analysis the natural logarithm of urine protein-to-creatinine ratio (UPCR) urine NAG-to-creatinine ratio, urine beta 2 microglobulin urine sodium-to-creatinine ratio | — |
Contacts
Public ContactSho Kinguchi
Yokohama City University Graduate School of Medicine
Outcome results
None listed