UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008835 |
|---|---|
| Receipt number | R000010346 |
| Scientific Title | Relationship between nutritional status during hospitalization and prognosis in patients with heart failure. |
| Date of disclosure of the study information | 2012/09/03 |
| Last modified on | 2021/09/09 12:59:03 |
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Basic information
Public title
Relationship between nutritional status during hospitalization and prognosis in patients with heart failure.
Acronym
Nutritional status and prognosis in heart failure.
Scientific Title
Relationship between nutritional status during hospitalization and prognosis in patients with heart failure.
Scientific Title:Acronym
Nutritional status and prognosis in heart failure.
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the relationship between nutritional status during hospitalization and prognosis in patients with heart failure.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Prognosis
2.CONUT
3.Mini Nutritional Assessment(MNA)
4.Subjective Global Assesment(SGA)
Key secondary outcomes
1.Transthoracic echocardiography
2.Abdominal muscle mass
3.Blood test
Prealbumin, Transferrin, Retinol-binding protein, Amino acids fractionation, Homocysteine, Total cholesterol, LDL cholesterol, HDL cholesterol, Triglyceride, Total lymphocyte count, Albumin, Fatty acids profile of lipids, Thyroid stimulating hormone(TSH), Free-Triiodothyronin(F-T3), Free-Thyroxin(F-T4), Hemoglobin A1c, Cystatin C, C-reactive protein(CRP), N-terminal pro-B-type natriuretic peptide(NT-proBNP), Interleukin-6(IL-6), Tumor Necrosis Factor-alpha(TNF-alpha)
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
Hospitalized patients with heart failure.
Key exclusion criteria
Patients who were determined as being ineligible for the study by the investigators or sub investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kida |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
TEL
0449778111
n2suzuki@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
TEL
0449778111
Homepage URL
n2suzuki@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
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
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
Tel
0449778111
k-sienbu.mail@marianna-u.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
| 2012 | Year | 09 | Month | 03 | 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
| 2012 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Age, gender, height, body weight, basal heart diseases, medication,
complications, frequency of hospitalization, number of days of hospitalization, activities of daily living, vital signs, symptom of heart failure, physical findings, nutritional assessment(CONUT, MNA, SGA), blood test(blood markers), echocardiography, Chest-Xray.
* A prospective study.
Management information
Registered date
| 2012 | Year | 09 | Month | 02 | Day |
Last modified on
| 2021 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010346
| 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 |
