UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009361 |
|---|---|
| Receipt number | 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 16:26:58 |
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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
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
minatos@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011000
