UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007846 |
|---|---|
| Receipt number | 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 13:50:47 |
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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
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
takada006@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Losartan study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009245
