Effect of sacubitril/valsartan versus valsartan on blood pressure in hypertensive patients with chronic heart failure and chronic kidney disease, a parallel-group randomized controlled trial
- Conditions
- Hypertension with chronic heart failure and chronic kidney disease
- Registration Number
- JPRN-UMIN000043657
- Lead Sponsor
- Yokohama City University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 62
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of change in clinic systolic blood pressure after 8 weeks
- Secondary Outcome Measures
Name Time Method 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.)