UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025838 |
|---|---|
| Receipt number | R000029710 |
| Scientific Title | Assessment of Pancreatic exocrine function of hospitalized patients with heart failure |
| Date of disclosure of the study information | 2017/01/25 |
| Last modified on | 2023/09/25 22:52:31 |
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Basic information
Public title
Assessment of Pancreatic exocrine function of hospitalized patients with heart failure
Acronym
Assessment of Pancreatic exocrine function of hospitalized patients with heart failure
Scientific Title
Assessment of Pancreatic exocrine function of hospitalized patients with heart failure
Scientific Title:Acronym
Assessment of Pancreatic exocrine function of hospitalized patients with heart failure
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Hepato-biliary-pancreatic medicine | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pancreatic exocrine function in patients with heart failure
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pancreatic exocrine function measured using PFD (pancreatic function diagnostic) test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Pancreatic functional diagnosis test
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
hospitalized patients with heart failure
hospitalized patients without heart failure
Key exclusion criteria
Patients with end-stage renal disease (eGFR<30 ml/min) including hemodialysis
Patients with acute pancreatitis
Patients with acute hepatitis
Patients with other diseases which may affect pancreatic exocrine function
Patients with the medicine which may affect pancreatic exocrine function
Pregnancy and patients who is possible to be pregnant
Patients who did not consent
Patients who are considered as inappropriate based on the principle investigators judgement
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University Hospital
Division name
Department of Cardiovasacular Medicine
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan.
TEL
03-3813-3111
tkasai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University Hospital
Division name
Department of Cardiovasacular Medicine
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan.
TEL
03-3813-3111
Homepage URL
tkasai@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
we have no funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Hospital Ethics Committee
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan.
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2017 | Year | 01 | Month | 25 | 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
| 2016 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029710
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
