Unique ID issued by UMIN | UMIN000043657 |
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Receipt number | R000049857 |
Scientific Title | 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 |
Date of disclosure of the study information | 2021/03/18 |
Last modified on | 2022/09/21 09:25:42 |
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
SaVa-CKD trial
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
SaVa-CKD trial
Japan |
Hypertension with chronic heart failure and chronic kidney disease
Cardiology | Nephrology | Adult |
Others
NO
To evaluate the efficacy of sacubitril/valsartan compared to valsartan in hypertensive patients with chronic heart failure and chronic kidney disease
Safety,Efficacy
Amount of change in clinic systolic blood pressure after 8 weeks
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.)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
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 continued for 6 weeks.
Valsartan 80mg once daily is administered for 4 weeks. After allocation, Valsartan 80mg is given for another 2 weeks. Then the dose will be increased to 100mg once daily and continued for 6 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
62
1st name | Nobuhito |
Middle name | |
Last name | Hirawa |
Yokohama City University Medical Center
Department of Nephrology and Hypertension
232-0024
4-57 Urafune-cho, Minami-ku, Yokohama City, Kanagawa-ken
0452615656
hirawa@yokohama-cu.ac.jp
1st name | Moe |
Middle name | |
Last name | Ozawa |
Yokohama City University Medical Center
Department of Nephrology and Hypertension
232-0024
4-57 Urafune-cho, Minami-ku, Yokohama City, Kanagawa-ken
0452615656
t196052d@yokohama-cu.ac.jp
Yokohama City University Medical Center
Yokohama City University
Self funding
Yokohama City University Ethics Committee
3-9 Fukuura, Kanazawa-ku, Yokohama City, Kanagawa-ken
045-370-7627
rinri@yokohama-cu.ac.jp
NO
2021 | Year | 03 | Month | 18 | Day |
Unpublished
Terminated
2021 | Year | 03 | Month | 16 | Day |
2021 | Year | 03 | Month | 16 | Day |
2021 | Year | 03 | Month | 16 | Day |
2022 | Year | 07 | Month | 12 | Day |
2021 | Year | 03 | Month | 18 | Day |
2022 | Year | 09 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049857
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