UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032796 |
|---|---|
| Receipt number | R000037407 |
| Scientific Title | Role of alpha-defensin produced by intestinal Paneth cells in heart failure |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2025/05/15 10:05:40 |
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Basic information
Public title
Role of alpha-defensin produced by intestinal Paneth cells in heart failure
Acronym
Role of alpha-defensin produced by intestinal Paneth cells in heart failure
Scientific Title
Role of alpha-defensin produced by intestinal Paneth cells in heart failure
Scientific Title:Acronym
Role of alpha-defensin produced by intestinal Paneth cells in heart failure
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the role of alpha-defensin produced by intestinal Paneth cells in the progression of heart failure
Basic objectives2
Others
Basic objectives -Others
To elucidate underlying mechanism of heart failure progression targeting regulation of gut microbiota
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal and blood alpha-defensin (HD5) originated from intestinal Paneth cells
Key secondary outcomes
Gut microbiota, systemic inflammation, systemic oxidative stress, rates of cardiovascular events (all-cause death, heart failure-related death, all-cause hospitalization, hospitalization for worsening heart failure) etc.
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
Patients with chronic heart failure who have a history of hospital admission or are admitted to the hospital due to congestive heart failure diagnosed by the Framingham criteria
Key exclusion criteria
1) A patient with active inflammation
2) A patient who is taking antibiotics or has a history of taking antibiotics within the past 1 month
3) A patient with inflammatory bowel disease
4) A patient taking steroid or anti-immunosuppressant medicine
5) A patient with malignant disease whose life expectancy is less than a year
6) A patient who has a plan of hospitalization due to scheduled examination or treatment within a year
7) A patient with ventricular assist device (VAD)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yokota |
Organization
Hokkaido University Hospital
Division name
Institute of Health Science Innovation for Medical Care
Zip code
060-8648
Address
Kita-14 Nishi-5, Kita-Ku, Sapporo, Japan
TEL
011-706-6001
t-yokota@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yokota |
Organization
Hokkaido University Hospital
Division name
Institute of Health Science Innovation for Medical Care
Zip code
060-8648
Address
Kita-14 Nishi-5, Kita-Ku, Sapporo, Japan
TEL
011-706-6001
Homepage URL
t-yokota@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Science and Technology Agency
IRB Contact (For public release)
Organization
Institutional Review Board of Hokkaido University Hospital
Address
Kita-14 Nishi-5, Kita-Ku, Sapporo 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.ac.jp
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
| 2018 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Prospective study
2) Case-control study
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2025 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037407
