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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008784
Receipt No. 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

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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
Email 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
Email tetsuro@juntendo.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine,
Juntendo University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010324

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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