UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053186 |
|---|---|
| Receipt number | R000060700 |
| Scientific Title | Dietary Status and Prognosis in Patients with Chronic Heart Failure |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2023/12/21 16:16:21 |
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Basic information
Public title
Dietary Status and Prognosis in Patients with Chronic Heart Failure
Acronym
Dietary Status and Prognosis in Patients with Chronic Heart Failure
Scientific Title
Dietary Status and Prognosis in Patients with Chronic Heart Failure
Scientific Title:Acronym
Dietary Status and Prognosis in Patients with Chronic Heart Failure
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of dietary status before and after hospitalization and nutritional management during hospitalization on prognosis in patients with chronic heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Combined end point of death or readmission 6 months after discharge
Key secondary outcomes
Readmission 6 months after discharge
Mortality 6 months after discharge
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized for chronic heart failure who have consented to the survey
Key exclusion criteria
Non-therapeutic hospitalization due to deterioration of medical condition
intubated patients
patients receiving NPPV
patients with pacemakers when body composition analysis is performed
patients who have difficulty in communication due to cognitive decline
patients who have difficulty in oral intake due to dysphagia
patients who are unable to take oral intake mainly through enteral and fluid management
patients hospitalized due to primary heart failure or acute heart failure
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Momoki |
Organization
Setsunan University
Division name
Faculty of Agriculture, Department of food science and human nutrition, Clinical nutrition
Zip code
5730101
Address
Nagaotoge-cho 45-1, Hirakata-City, Osaka
TEL
0728966207
chika.momoki@setsunan.ac.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Momoki |
Organization
Setsunan University
Division name
Faculty of Agriculture, Department of food science and human nutrition, Clinical nutrition
Zip code
5730101
Address
Nagaotoge-cho 45-1, Hirakata-City, Osaka
TEL
0728966207
Homepage URL
chika.momoki@setsunan.ac.jp
Sponsor or person
Institute
Setsunan University
Institute
Department
Personal name
Chika Momoki
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Rousai Hospital Ageo Central General Hospital Higashisumiyoshi Morimoto Hospital Osaka Metropolitan University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Setsunan University Research Support Social Collaboration Center
Address
17-8 Ikedanaka-machi,Osaka
Tel
0728290385
YOSHIDA.Yuichiro@josho.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
| 2024 | Year | 01 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the factors contributing to prognosis and readmission due to deterioration in the nutritional and dietary conditions during hospitalization
Management information
Registered date
| 2023 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060700
| 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 |
