UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022414 |
|---|---|
| Receipt number | R000025812 |
| Scientific Title | The interaction between gut microbiota and heart failure |
| Date of disclosure of the study information | 2016/05/23 |
| Last modified on | 2018/04/13 19:39:04 |
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Basic information
Public title
The interaction between gut microbiota and heart failure
Acronym
Gut microbiota and heart failure
Scientific Title
The interaction between gut microbiota and heart failure
Scientific Title:Acronym
Gut microbiota and heart failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the composition of gut microbiota in patients with heart failure, compared with controls without heart failure
Basic objectives2
Others
Basic objectives -Others
To clarify the change of gut microbiota during therapy and association of gut microbiota with prognosis in patients with heart failure
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Gut microbiota
Key secondary outcomes
The metabolites of gut microbiota
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Heart failure patients who were diagnosed by Framingham criteria
Controls without heart failure who have hypertension, diabetes, or dyslipidemia
Key exclusion criteria
Patients with collagen disease, malignancy, bowel disease, or kidney disease
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Hirata |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5846
hiratak@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Yamashita |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5846
Homepage URL
tomoya@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Division of Cardiovascular Medicine, Depatment of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Institute of Technology
Name of secondary funder(s)
None
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
| 2016 | Year | 05 | Month | 23 | 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
| 2016 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Management information
Registered date
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2018 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025812
