UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043657
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

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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 or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049857


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name