Hypertension with chronic heart failure and chronic kidney disease
Conditions
Interventions
Valsartan 80mg once daily is administered for 4 weeks. After allocation, treatment changes to sacubitril/valsartan 50mg twice daily. After 2 weeks, dose will be increased to 100mg twice daily and con
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Chronic heart failure Follow the diagnostic criteria of Guidelines for Diagnosis and Treatment of Acute and Chronic Heart Failure(JCS 2017/JHFS 2017). 1.There are findings suggestive of heart failure such as diuretic use and lower leg edema. 2.NT-proBNP is not less than 400pg/mL or BNP is not less than 100pg/mL 3.Patients diagnosed with chronic heart failure and receiving treatment. 4.ACCF/AHA Stages of heart failure 3 5.NYHA Functional Classification 1-3 2.eGFR <45ml/min/1.732 3.UPCR is 0.15g/gCr or more, <3.5g/gCr 4.Clinic systolic blood pressure is not lower than 130mmHg or clinic diastolic blood pressure is not lower than 80mmHg. 5.Age 20 years and over
Exclusion criteria
Exclusion criteria: 1.Bilateral renal artery stenosis or renal artery stenosis in piece renal patients 2.Pregnancy, lactating women 3.Serum potassium >5.5mEq/L 4.Ischaemic heart disease and stroke in 6 months prior to Screening 5.History if angioedema 6.Severe liver failure(Child-Pugh C) or ALT/AST is more than twice the normal upper limit at Screening 7.History of hypersensitivity to sacubitril/valsartan 8.Diabetes mellitus on current treatment with aliskiren 9.Patients judged by the investigator to be unsuitable as subjects 10.Chronic lung disease requiring home oxygen administration 11.Patients who need to introduce renal replacement therapy within 6 months 12.Clinic or home systolic blood pressure is 200mmHg or higher. 13.Heart failure requiring oxygen administration 14.Serum Cr level increased by more than 30% in the last 3 months 15.If patients take ARB at registration, the dose is higher than half of the maximum daily dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in clinic systolic blood pressure after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Amount of change in clinic diastolic blood pressure, home blood pressure, and 24-hour ambulatory blood pressure monitoring(ABPM) 2.Amount and rate of change in renal function(Cr, eGFR) and proteinurea(UPCR) 3.Body weight change 4.Amount of change in NT-proBNP 5.Amount of change in cardiothoracic ratio 6.Amount of change in plasma cGMP, urinary renal impairment markers(NAG, Beta-2 Microglobulin, 8-OHdG, etc.) | — |
Countries
Japan
Contacts
Public ContactMoe Ozawa
Yokohama City University Medical Center Department of Nephrology and Hypertension
Outcome results
None listed