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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007846
Receipt No. R000009245
Scientific Title Reserch on the effect of losartan on diastolic heart failure patients with hyperuricemia
Date of disclosure of the study information 2012/05/01
Last modified on 2012/04/27

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Basic information
Public title Reserch on the effect of losartan on diastolic heart failure patients with hyperuricemia
Acronym Losartan study
Scientific Title Reserch on the effect of losartan on diastolic heart failure patients with hyperuricemia
Scientific Title:Acronym Losartan study
Region
Japan

Condition
Condition Elderly diastolic heart failure patients with hyperuricemia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison between the effect of ACE-inhibitor and losartan on elderly diastolic heart failure patients with hyperuricemia in terms of uric acid level and diastolic dysfunction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of uric acid level
Key secondary outcomes 1.NYHA
2.Rho-kinase activity of circulating leukocyte
3.cyclophilin A, 8-isoproatane
4.pentraxin3, Hs-CRP
5.NT-proBNP
6.renin activity, aldsterone activity
7.echocardiography: ejection fraction, diastolic function(E/A,E/e')
8.flow mediated dilation
9.urinary albumin-to-creatinine ratio
10.Hospitalization for worsenig heart failure,all cause death

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Losartan(12 week)
Interventions/Control_2 ACE-inhibitor(12 week)
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
65 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 65 years old or over
Hypertension
Undertreatment of ACE inhibitor
Serum uric acid level 7.0mg/dl or over
Key exclusion criteria Medication for high uric acid
Creatinine level 2.0mg/dl or over
Serum potassium level 5.0meq/l or over
Clinical history of Gouty attack
Undertreatment of angiotensin receptor blocker
NYHA4
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Takahashi
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1,Seiryo-machi, Aoba-ku,Sendai
TEL 022-717-7153
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Takada
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1,Seiryo-machi, Aoba-ku,Sendai
TEL 022-717-7153
Homepage URL
Email takada006@cardio.med.tohoku.ac.jp

Sponsor
Institute Losartan study group
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 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 Preinitiation
Date of protocol fixation
2012 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 05 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

Management information
Registered date
2012 Year 04 Month 27 Day
Last modified on
2012 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009245

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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