UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028070 |
|---|---|
| Receipt number | R000031282 |
| Scientific Title | Characteristics of visit-to-visit blood pressure variability in hemodialysis patients |
| Date of disclosure of the study information | 2017/07/07 |
| Last modified on | 2021/07/18 14:47:22 |
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Basic information
Public title
Characteristics of visit-to-visit blood pressure variability in hemodialysis patients
Acronym
Prognostic significance of visit-to-visit blood pressure variability in hemodialysis patients
Scientific Title
Characteristics of visit-to-visit blood pressure variability in hemodialysis patients
Scientific Title:Acronym
Prognostic significance of visit-to-visit blood pressure variability in hemodialysis patients
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prognostic significance of visit-to-visit blood pressure variability in hemodialysis patients
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Prognostic significance of visit-to-visit blood pressure variability in hemodialysis patients
Key secondary outcomes
Association between visit-to-visit blood pressure variability and background factors in hemodialysis patients
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
maintenance hemodialysis patients
Key exclusion criteria
the cases which were not followed for 60 months
Target sample size
325
Research contact person
Name of lead principal investigator
| 1st name | yoshifumi |
| Middle name | |
| Last name | amari |
Organization
Moriguchi-Keijinn-Kai Hospital
Division name
Nephrology
Zip code
570-0021
Address
2-47-12, Yagumohigashimachi, Moriguchi-City, Osaka
TEL
09087501926
yoshifumi.0315@gmail.com
Public contact
Name of contact person
| 1st name | yoshifumi |
| Middle name | |
| Last name | amari |
Organization
Moriguchi-Keijinn-Kai Hospital
Division name
Nephrology
Zip code
570-0021
Address
2-47-12, Yagumohigashimachi, Moriguchi-City, Osaka
TEL
06-6906-9000
Homepage URL
yoshifumi.0315@gmail.com
Sponsor or person
Institute
Moriguchi-Keijinn-Kai Hospital
Institute
Department
Personal name
Funding Source
Organization
Moriguchi-Keijinn-Kai Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Moriguchi Keijinkai Hospital
Address
2-47-12, Yagumohigashimachi, Moriguchi-City, Osaka
Tel
09087501926
yoshifumi.0315@gmail.com
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
| 2017 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
February 2019Hypertension Research 42(Suppl 3):1 DOI:10.1038/s41440-019-0231-9
Number of participants that the trial has enrolled
324
Results
The present study presents data that VIM in SBP and other SBP parameters during HD therapy are reproducible and associated with various background factors. Also, pre-VIM-SBP is independently correlated with cardiovascular mortality. Pre-VIM-SBP could be used as a predictive marker for cardiovascular events in HD patients. Further studies are necessary to confirm the mechanism for underlying increases in VVBPV and to clarify whether reducing VVBPV improves prognoses for HD patients.
Results date posted
| 2021 | Year | 07 | Month | 18 | Day |
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
| 2017 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We measured visit-to-visit blood pressure variability in hemodialysis patients, and
analyzed the relationship between mentioned status and prognosis after 5 years.
Management information
Registered date
| 2017 | Year | 07 | Month | 04 | Day |
Last modified on
| 2021 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031282
| Research Plan | |
|---|---|
| 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 |
