UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047193 |
|---|---|
| Receipt number | R000053834 |
| Scientific Title | Survey on Nutritional Management for Heart Failure Patients |
| Date of disclosure of the study information | 2022/03/18 |
| Last modified on | 2022/03/17 10:27:43 |
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Basic information
Public title
Survey on Nutritional Management for Heart Failure Patients
Acronym
Survey on Nutritional Management for Heart Failure Patients
Scientific Title
Survey on Nutritional Management for Heart Failure Patients
Scientific Title:Acronym
Survey on Nutritional Management for Heart Failure Patients
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the actual status of how nutritional assessment and management is performed in Stage C heart failure patients, and to gain insight into the development of nutrition intervention protocols to improve the risk of low nutrition or undernutrition.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nutrition/frail sarcopenia/cardiac cachexia assessment
Key secondary outcomes
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
Physicians enrolled in institutions with a past record of collaboration with Juntendo Medical School's Department of Cardiology
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Matsue |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-0033
Address
3-3-9, Hongo, Bunkyo-Ku, Tokyo
TEL
0338133111
y-matsue@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Dotare |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-0033
Address
3-3-9, Hongo, Bunkyo-Ku, Tokyo
TEL
08032145887
Homepage URL
t-dotare@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
EN Otsuka Pharmaceutical Co.
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
Research Ethics Commiittee, Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-Ku, Tokyo
Tel
0358021584
hongo-rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
E21-0303
Org. issuing International ID_1
Research Ethics Commiittee, Faculty of Medicine, Juntendo University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 18 | 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
| 2022 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 03 | Month | 17 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053834
