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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009361
Receipt No. R000011000
Scientific Title Investigation of the effect of endogenous GLP-1 on cardiac function in chronic heart failure
Date of disclosure of the study information 2012/11/20
Last modified on 2015/05/19

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Basic information
Public title Investigation of the effect of endogenous GLP-1 on cardiac function in chronic heart failure
Acronym GLP-1 and cardiac function
Scientific Title Investigation of the effect of endogenous GLP-1 on cardiac function in chronic heart failure
Scientific Title:Acronym GLP-1 and cardiac function
Region
Japan

Condition
Condition Patients with chronic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between plasma GLP-1 level and cardiac function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To assess the relationship between plasma GLP-1 level and left ventricular ejection fraction
Key secondary outcomes To assess the relationship between plasma GLP-1 level and plasma BNP level

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with LV ejection fraction smaller than 40 %
Key exclusion criteria Patients that doctors judged as inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Minatoguchi
Organization Gifu University
Division name Department of Cardiology
Zip code
Address Yanagido 1-1, Gifu
TEL 058-230-6520
Email minatos@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Minatoguchi
Organization Gifu University
Division name Department of Cardiology
Zip code
Address Yanagido 1-1, Gifu
TEL 058-230-6520
Homepage URL
Email minatos@gifu-u.ac.jp

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization Gifu University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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
2012 Year 11 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2012 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 20 Day
Last follow-up date
2013 Year 10 Month 20 Day
Date of closure to data entry
2013 Year 10 Month 20 Day
Date trial data considered complete
2013 Year 10 Month 20 Day
Date analysis concluded
2013 Year 10 Month 30 Day

Other
Other related information We will start the enrolling.

Management information
Registered date
2012 Year 11 Month 19 Day
Last modified on
2015 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011000

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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