UMIN-CTR Clinical Trial

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
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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
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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
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Results Delayed
Results Delay Reason
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Baseline Characteristics
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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
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Research case data
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