UMIN-CTR Clinical Trial

Basic information
Public 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
Acronym	SaVa-CKD trial
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
Scientific Title:Acronym	SaVa-CKD trial
Region	Japan

Condition
Condition	Hypertension with chronic heart failure and chronic kidney disease
Classification by specialty	Cardiology Nephrology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of sacubitril/valsartan compared to valsartan in hypertensive patients with chronic heart failure and chronic kidney disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of change in clinic systolic blood pressure after 8 weeks
Key secondary outcomes	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.)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2	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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	62

Research contact person
Name of lead principal investigator	1st name Nobuhito Middle name Last name Hirawa
Organization	Yokohama City University Medical Center
Division name	Department of Nephrology and Hypertension
Zip code	232-0024
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, Kanagawa-ken
TEL	0452615656
Email	hirawa@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Moe Middle name Last name Ozawa
Organization	Yokohama City University Medical Center
Division name	Department of Nephrology and Hypertension
Zip code	232-0024
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, Kanagawa-ken
TEL	0452615656
Homepage URL
Email	t196052d@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Ethics Committee
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, Kanagawa-ken
Tel	045-370-7627
Email	rinri@yokohama-cu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2021 Year 03 Month 16 Day
Date of IRB	2021 Year 03 Month 16 Day
Anticipated trial start date	2021 Year 03 Month 16 Day
Last follow-up date	2022 Year 07 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 18 Day
Last modified on	2022 Year 09 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049857