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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000622
Receipt No. R000000754
Scientific Title Heart Failure management by COmbination of STatin and ARB
Date of disclosure of the study information 2007/03/01
Last modified on 2008/04/02

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Basic information
Public title Heart Failure management by COmbination of STatin and ARB
Acronym HF-COSTAR
Scientific Title Heart Failure management by COmbination of STatin and ARB
Scientific Title:Acronym HF-COSTAR
Region
Japan

Condition
Condition Chronic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We assessed whether the use of a combination therapy of the ARB (losartan, LOS) and statin (simvastatin, SIM) causes the beneficial effect on chronic heart failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hositalization and death caused by heart failure
Left ventricular ejection fraction (measured by echocardiography)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 ARB group
Interventions/Control_2 ARB+STATIN group
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
80 years-old >=
Gender Male and Female
Key inclusion criteria The patients of chronic heart failure
Key exclusion criteria The patient who is improper of this study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuaki Isobe
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine
Zip code
Address yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Cardiovascular Medicine, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization BANYU Pharmaceuticals Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Cardiovascular Medicine, Akita University
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

Other administrative information
Date of disclosure of the study information
2007 Year 03 Month 01 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 Completed
Date of protocol fixation
2003 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2003 Year 08 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 03 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2008 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 02 Month 28 Day
Last modified on
2008 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000754

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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