UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044903 |
|---|---|
| Receipt number | R000051288 |
| Scientific Title | Evaluation of autonomic function using heart rate response during exercise in patients receiving hemodialysis: Association with intradialytic hypotension and, cardiovascular and all-cause mortality |
| Date of disclosure of the study information | 2021/07/19 |
| Last modified on | 2022/01/17 09:41:14 |
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Basic information
Public title
Evaluation of autonomic function using heart rate response during exercise in patients receiving hemodialysis: Association with intradialytic hypotension and, cardiovascular and all-cause mortality
Acronym
Heart rate response during exercise and cardiovascular and all-cause mortality in patients receiving hemodialysis
Scientific Title
Evaluation of autonomic function using heart rate response during exercise in patients receiving hemodialysis: Association with intradialytic hypotension and, cardiovascular and all-cause mortality
Scientific Title:Acronym
Heart rate response during exercise and cardiovascular and all-cause mortality in patients receiving hemodialysis
Region
| Japan |
Condition
Condition
End stage kidney disease
Classification by specialty
| Cardiology | Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the heart rate profile during exercise test and the risk of mortality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Heart rate recovery
Heart rate reserve
Mortality
Key secondary outcomes
Intradialytic hypotension
Exercise capacity
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult outpatients receiving hemodialysis who underwent an exercise test
Key exclusion criteria
Nonachievement of test protocol
Presence of artificial heart pacemakers
Atrial fibrillation during the test
Loss of follow-up within 1 month after testing
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Usui |
Organization
Kisen Hospital
Division name
Department of Rehabilitation
Zip code
125-0041
Address
1-35-8 Higashikanamachi, Katsushika-ku, Tokyo, Japan
TEL
03-3600-9007
usui@kisen.or.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Usui |
Organization
Kisen Hospital
Division name
Department of Rehabilitation
Zip code
125 - 0041
Address
1-35-8 Higashikanamachi, Katsushika-ku, Tokyo, Japan
TEL
03-3600-9007
Homepage URL
usui@kisen.or.jp
Sponsor or person
Institute
Kisen Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethical Review Board of Kisen Hospital
Address
1-35-8 Higashikanamachi, Katsushika-ku, Tokyo, Japan
Tel
03-3600-9007
tomura@kisen.or.jp
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
嬉泉病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 19 | 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
273
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
| 2020 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 15 | Day |
Other
Other related information
Examination of the relationship between heart rate profile obtained from exercise test and intradialytic hypotension and mortality
Management information
Registered date
| 2021 | Year | 07 | Month | 19 | Day |
Last modified on
| 2022 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051288
