UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000659 |
|---|---|
| Receipt number | R000000786 |
| Scientific Title | Effect of ARB on ambulatory blood pressure and cardiovascular remodeling in hypertensives on hemodialysis |
| Date of disclosure of the study information | 2008/11/01 |
| Last modified on | 2015/09/19 09:52:20 |
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Basic information
Public title
Effect of ARB on ambulatory blood pressure and cardiovascular remodeling in hypertensives on hemodialysis
Acronym
Effect of ARB on ambulatory blood pressure and cardiovascular remodeling in hypertensives on hemodialysis
Scientific Title
Effect of ARB on ambulatory blood pressure and cardiovascular remodeling in hypertensives on hemodialysis
Scientific Title:Acronym
Effect of ARB on ambulatory blood pressure and cardiovascular remodeling in hypertensives on hemodialysis
Region
| Japan |
Condition
Condition
Hypertension, end-stage renal failure on hemodialysis
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will examine a possible beneficial effect of ARB on ambulatory blood pressure profiles and cardiovascular remodeling in hypertensives on hemodialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
1) Ambulatory BP monitering (mean BP, BP and HR variability)
2) UCG, carotid echogram (IVSd, LVDd, LVPWd, LVDs, FS, EF, E/A, DcT, LAD, IMT)
3) ABI/baPWV
4) Blood chemistry
Endocrine: catecholamine, ANP, BNP, PRA, PAC
Coagulation: fibrinogen
Glucose: blood glucose, IRI
Serological: CRP
Oxidative stress: adiponectin, MDA-LDL, AGE
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Losartan group: Start with once-daily dosing of losartan 25-50 mg, and increase up to 50-100 mg if effect of losartan on the clinical parameters is insufficient. Target blood pressure is less than 140/90 mmHg.
Interventions/Control_2
Control therapy group: Treated with anti-hypertensives principally by other than ARBs or ACE inhibitors.Target blood pressure is less than 140/90 mmHg.
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
Patients who just started mainetenance hemodialysis for ESRD with blood pressure>=140/90.
Key exclusion criteria
Malignancy, acute myocardial infarction/unstable angina, collagen diseases, acute renal failure, severe liver disorder, history of hypersensitivity to the administered ARB, pregnant women, or women suspected of being pregnant
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouichi TAMURA |
Organization
Yokohama City University School of Medicine
Division name
Deaprtment of Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2635
tamukou@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kazuaki UCHINO |
Organization
Yokohama City University School of Medicine
Division name
Deaprtment of Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2800
Homepage URL
http://www-user.yokohama-cu.ac.jp/
uchinok@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yokohama Minami-Kyosai Hospital, Kosaikai Asahi Hospital, Fujisawa Municipal Hospital
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2004 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 03 | Month | 28 | Day |
Last modified on
| 2015 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000786
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
