UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004339 |
|---|---|
| Receipt number | R000005196 |
| Scientific Title | Urinary 8-Hydroxy-2'-Deoxyguanosine as a new oxidative stress biomarker in patients with chronic heart failure |
| Date of disclosure of the study information | 2010/10/15 |
| Last modified on | 2010/10/06 19:54:48 |
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Basic information
Public title
Urinary 8-Hydroxy-2'-Deoxyguanosine as a new oxidative stress biomarker in patients with chronic heart failure
Acronym
heart failure and oxidative stress
Scientific Title
Urinary 8-Hydroxy-2'-Deoxyguanosine as a new oxidative stress biomarker in patients with chronic heart failure
Scientific Title:Acronym
heart failure and oxidative stress
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate theefficacy of biomarker of oxidative stress
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)the relation between a biomarker of oxidative stress and heaart failure severity
2)the relation between a biomarker of oxidative stress and prognosis in patients with heart failure
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
heart failure
Key exclusion criteria
cancer
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masunori Matsuzaki |
Organization
Yamaguchi University
Division name
Department of Medicine and Clinical Science
Zip code
Address
Yamaguchi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kobayashi |
Organization
Yamaguchi
Division name
Department Clinical Science
Zip code
Address
TEL
0836-22-2248
Homepage URL
Sponsor or person
Institute
Department Clinical Science
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Science
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
| 2010 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
evaluation of heart failure severity and prognosis
Management information
Registered date
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2010 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005196
