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Recruitment status Completed
Unique ID issued by UMIN UMIN000014113
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email mitsuhashi3615@yahoo.co.jp

Sponsor
Institute Research office of Study of effect of UA decrease treatment on LVH
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016429


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