UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029420 |
|---|---|
| Receipt number | R000031590 |
| Scientific Title | Clinical study on energy metabolism of heart failure patients |
| Date of disclosure of the study information | 2017/10/15 |
| Last modified on | 2022/10/14 13:23:09 |
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Basic information
Public title
Clinical study on energy metabolism of heart failure patients
Acronym
Clinical study on energy metabolism of heart failure patients
Scientific Title
Clinical study on energy metabolism of heart failure patients
Scientific Title:Acronym
Clinical study on energy metabolism of heart failure patients
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to establish nutritional therapy according to severity and cardiac function of heart failure patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between energy balance and cardiac function
Key secondary outcomes
1) Relationship between nutritional status at hospitalization and severity of heart failure
2) Relation between resting energy expenditure, consumption of carbohydrates and lipids and severity of heart failure
3) Relationship between muscle mass, body fat mass and severity of heart failure obtained by impedance method
4) Relationship between inflammatory cytokines, appetite regulators and the severity of heart failure
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
heart failure patients
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 admitted to cardiovascular internal medicine for the purpose of treating heart failure between August 2017 and March 2021 are targeted.
Key exclusion criteria
1) Minors
2) Patients with malignant tumor complications
3) Patients complicated with diseases affecting energy metabolism, such as chronic obstructive pulmonary disease, hyperthyroidism, hypothyroidism, severe infections
4) Patients wearing pacemaker
5) Others attending physician was deemed inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Sasaki |
Organization
Shiga University Hospital
Division name
Division of Clinical Nutrition
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL
077-548-2518
sasaki@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Yasuhara |
Organization
Shiga University Hospital
Division name
Division of Clinical Nutrition
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL
077-548-2518
Homepage URL
yasu5288@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University Hospital
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
Tel
077-548-2518
yasu5288@belle.shiga-med.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 | 10 | Month | 15 | 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
| 2017 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 10 | 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
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031590
