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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030758
Receipt No. 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

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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
Institute Division of Cardiovascular center, Tokyo General Hospital
Institute
Department

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
URL(English) https://upload.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


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