UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014113 |
|---|---|
| Receipt number | R000016429 |
| Scientific Title | Study about effect of agressive uric acid decrease treatment on left ventricular hypertrophy |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2018/11/28 15:58:58 |
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Basic information
Public title
Study about effect of agressive uric acid decrease treatment on left ventricular hypertrophy
Acronym
study about UA and LVH
Scientific Title
Study about effect of agressive uric acid decrease treatment on left ventricular hypertrophy
Scientific Title:Acronym
study about UA and LVH
Region
| Japan |
Condition
Condition
LeftVentricular Hypertrophy
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effect of uric acid decrease treatment on left ventricular hypertrophy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Left Ventricular Mass
Key secondary outcomes
Cardiovascular event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
LVH patients are divided into 2 groups: agressive UA decrease treatment group and standard treatment group. Patients of agressive UA decrease treatment group will have UA decrease treatment
Interventions/Control_2
Patients who are assigned as a standard therapy do not receive UA decrease treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) LVH patients who are diagnosed by echocardiogram
2) Patients who ha have normal or high UA level
3) Older than 20 years old
4) Patients who consented to the study
Key exclusion criteria
1) Patients who has cardiomyopathy or valvular disease
2) Patients who has coronary artery diasese
3) Paitents who has congenital heart disease
4) Patients who has severe hepatic or renal diasese
5) Patinets who is taking diuretics
6) Patients who is allergic to Febxiostat
7) Pregnant or mother who is providing breast milk
8) Patients who doctor in charge diagnosed to be inappropriate for the study
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Mitsuhashi |
Organization
St Luke's International Hospital
Division name
Cardiovascular center
Zip code
Address
9-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-3541-5151
mitsuhashi3615@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Mitsuhashi |
Organization
St Luke's International Hospital
Division name
Cardiovascular center
Zip code
Address
9-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-3541-5151
Homepage URL
mitsuhashi3615@yahoo.co.jp
Sponsor or person
Institute
Research office of Study of effect of UA decrease treatment on LVH
Institute
Department
Personal name
Funding Source
Organization
Research office of Study of effect of UA decrease treatment on LVH
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
聖路加国際病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 29 | Day |
Last modified on
| 2018 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016429
