UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030758
Receipt number R000035124
Scientific Title Benefit in upgRading Of duretics with ADministration of loW dose tolvAptan therapY for chronic heart failure in Southern Tohoku reseArch institute for neuRoscience
Date of disclosure of the study information 2018/01/19
Last modified on 2018/01/11 01:42:14

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Basic information

Public title

Benefit in upgRading Of duretics with ADministration of loW dose tolvAptan therapY for chronic heart failure in Southern Tohoku reseArch institute for neuRoscience

Acronym

Broadway-STAR study

Scientific Title

Benefit in upgRading Of duretics with ADministration of loW dose tolvAptan therapY for chronic heart failure in Southern Tohoku reseArch institute for neuRoscience

Scientific Title:Acronym

Broadway-STAR study

Region

Japan


Condition

Condition

heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was efficacy and safety of low dose Tolvaptan for chronic heart failure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The rate of re-hospitalization and changes of renal function during 3 years.

Key secondary outcomes

1)body weight
2)congestion
3)renal function
4)cardiac function
5)event


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

reduction of loop diuretic and administration of low dose TLV(2mg/day)

Interventions/Control_2

sustained administration of loop diuretic

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1)patient of peroral administration of loop diuretic
2)eGFR>30 mL/min/1.73m2
3) more than 20 years old
4) patient of hospitalization
5) Patient with consent ability

Key exclusion criteria

1)Intravenous injection and mechanical support
2)history of hypersensitivity of TLV
3)anuria
4)difficulty of drinking water
5)hypernatremia
6)pregnancy
7)oral administration of TLV
8)acute coronary syndrome
9)Inappropriate patient

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideyuki Takimura

Organization

Tokyo General Hospital

Division name

Division of Cardiovascular center

Zip code


Address

3-15-2, Egota, Nakanoku, Tokyo

TEL

03-3387-5421

Email

hideyuki.takimura@mt.strins.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideyuki Takimura

Organization

Tokyo General Hospital

Division name

Division of Cardiovascular center

Zip code


Address

3-15-2, Egota, Nakanoku, Tokyo

TEL

03-3387-5421

Homepage URL


Email

hideyuki.takimura@mt.strins.or.jp


Sponsor or person

Institute

Division of Cardiovascular center, Tokyo General Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Southern Tohoku Research institute for neuroscience

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

総合東京病院,南東北グループ病院


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 19 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

Open public recruiting

Date of protocol fixation

2018 Year 01 Month 05 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 11 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry

2022 Year 01 Month 31 Day

Date trial data considered complete

2022 Year 02 Month 28 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 01 Month 11 Day

Last modified on

2018 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035124


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name