UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study about effect of agressive uric acid decrease treatment on left ventricular hypertrophy
Title of the study (Brief title)	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	Hirotsugu Mitsuhashi
Organization	St Luke's International Hospital
Division name	Cardiovascular center
Address	9-1 Akashi-cho, Chuo-ku, Tokyo
TEL	03-3541-5151
Email	mitsuhashi3615@yahoo.co.jp

Public contact
Name of contact person	Hirotsugu Mitsuhashi
Organization	St Luke's International Hospital
Division name	Cardiovascular center
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016429