UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009100 |
|---|---|
| Receipt number | R000010669 |
| Scientific Title | Prognostic Value of Serum Sodium Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction |
| Date of disclosure of the study information | 2012/10/15 |
| Last modified on | 2014/01/06 16:57:41 |
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Basic information
Public title
Prognostic Value of Serum Sodium Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction
Acronym
Prognostic Value of Serum Sodium Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction
Scientific Title
Prognostic Value of Serum Sodium Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction
Scientific Title:Acronym
Prognostic Value of Serum Sodium Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction
Region
| Japan |
Condition
Condition
Heart failure with normal left ventricular ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prognostic Value of Serum Sodium Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction
Basic objectives2
Others
Basic objectives -Others
prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CV death, non-fatal myocardial infarction or ischemic stroke, unstable angina pectoris, hospitalization for HF, or coronary revascularization
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a presence of HF symptoms
2 LVEF>50%
3 E/e'>15,or 8<E/e'<15 and BNP>200
Key exclusion criteria
Severe valvular heart disease
Chronic renal failure requiring hemodialysis
Active systemic inflammatory disease
Severe collagen disease
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Ogawa |
Organization
Kumamoto University Graduate School of Medical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo,Kumamotoshichuo-ku,Kumamoto-ken JAPAN
TEL
096-373-5175
ogawah@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Kusaka |
Organization
Kumamoto University Graduate School of Medical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo,Kumamotoshichuo-ku,Kumamoto-ken JAPAN
TEL
096-373-5175
Homepage URL
kusaka@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University Graduate School of Medical Sciences ,Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization
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 | 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
| 2006 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 09 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
HFNEF patients were followed prospectively every month at the outpatient clinic until July 2012 or until an endpoint occurred.
Management information
Registered date
| 2012 | Year | 10 | Month | 12 | Day |
Last modified on
| 2014 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010669
