UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008784 |
|---|---|
| Receipt number | R000010324 |
| Scientific Title | Clinical significanse of estimated sodium excretion of spot urine at outpatient in patients with chronic heart failure |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2015/08/28 10:18:35 |
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Basic information
Public title
Clinical significanse of estimated sodium excretion of spot urine at outpatient in patients with chronic heart failure
Acronym
Clinical significanse of estimated sodium excretion of spot urine at outpatient in patients with chronic heart failure
Scientific Title
Clinical significanse of estimated sodium excretion of spot urine at outpatient in patients with chronic heart failure
Scientific Title:Acronym
Clinical significanse of estimated sodium excretion of spot urine at outpatient in patients with chronic heart failure
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the associatin betwen estimated sodium excretion by sodium and creatinine concentrations of spot urine at outpatient and risk of cardiovascular event
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) admission due to chronic heart failure
2) change of sodium and potassium concentration of spot urin
3) change of NT-proBNP levels
Key secondary outcomes
1) Incident of MACCE (All cauth death, cardiac death, acute coronary syndrome, cerebral infarction and admission due to chronic heart failure)
2) Ejecton fraction by echocadiogram
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
1) Patients who admitted to our hospital due to chronic heart failure
2)Patients who give informed consent
Key exclusion criteria
1) Patients who are received hemodialysis
2) Patients who are schduled for CABG, PCI and surgery of valvular disease
3) Patients who have malignancy
4) Patients who have metabolic disorder influencing sodium and potassium excetion
5) Pregnant woman
6) Patients judged to be unsuitable participants by physician-in-charge
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Miyazaki |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
tetsuro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuro Miyazaki |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
tetsuro@juntendo.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Juntendo 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
Address
Tel
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 | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate the clinical laboratoly test results as below on admittion, at discharge and at first outpatient visit.
1) daily sodium and potassium excretion, sodium, potassium and creatinine concenrtation of spot urine
2) Serum levels of sodium, potassium, creatinine, hs-CRP, NT-proBNP, cystatin-C
3) Body weught, body mass index, blood pressure, pulse rate
4) Renal and liver functin tests
5) Microalbuminuria and L-FABP in spot urine
We also invesigate the association between casrdiovascular events and chages of estimated daily sodium excretion from spot urine from discharge to first outpatient visit.
Management information
Registered date
| 2012 | Year | 08 | Month | 28 | Day |
Last modified on
| 2015 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010324
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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