UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044773
Receipt number R000051139
Scientific Title Effect of sacubitril-valsartan on cardiac function in hemodialysis patients
Date of disclosure of the study information 2021/07/06
Last modified on 2021/07/06 16:46:42

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Basic information

Public title

Effect of sacubitril-valsartan on cardiac function in hemodialysis patients

Acronym

Sacubitril-valsartan in hemodialysis patients

Scientific Title

Effect of sacubitril-valsartan on cardiac function in hemodialysis patients

Scientific Title:Acronym

Sacubitril-valsartan in hemodialysis patients

Region

Japan


Condition

Condition

heart failure

Classification by specialty

Cardiology Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the effect of sacubitril-valsartan on cardiac function in hemodialysis patients with heart failure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in left ventricular ejection fraction and N-terminal proBNP level(pre, 4, 8 and 12 weeks).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

50 mg of sacubitril-valsartan twice daily at least 12 weeks

Interventions/Control_2


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

30 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

LVEF<50% or N-terminal proBNP >5000 ng/L

Key exclusion criteria

sys. BP <120 mmHg

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Shoichiro
Middle name
Last name Daimon

Organization

Daimon Clinic for Internal Medicine, Nephrology and Dialysis

Division name

Department of Nephrology

Zip code

921 8802

Address

Oshino 1-400, Nonoichi, Japan

TEL

+81762940077

Email

dai-clinic@m2.spacelan.ne.jp


Public contact

Name of contact person

1st name Shoichiro
Middle name
Last name Daimon

Organization

Daimon Clinic for Internal Medicine, Nephrology and Dialysis

Division name

Department of Nephrology

Zip code

921 8802

Address

Oshino 1-400, Nonoichi, Japan

TEL

+81762940077

Homepage URL


Email

dai-clinic@m2.spacelan.ne.jp


Sponsor or person

Institute

Daimon Clinic for Internal Medicine, Nephrology and Dialysis

Institute

Department

Personal name



Funding Source

Organization

No funding was received for this study

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

Daimon Clinic for Internal Medicine, Nephrology and Dialysis

Address

Oshino 1-400, Nonoichi, Japan

Tel

+81762940077

Email

dai-clinic@m2.spacelan.ne.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 07 Month 06 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

7

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

Completed

Date of protocol fixation

2020 Year 10 Month 01 Day

Date of IRB

2020 Year 10 Month 10 Day

Anticipated trial start date

2020 Year 11 Month 02 Day

Last follow-up date

2021 Year 01 Month 25 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 07 Month 06 Day

Last modified on

2021 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051139


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name