UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045681 |
|---|---|
| Receipt number | R000052104 |
| Scientific Title | Early detection of asymptomatic cardiac reserve disorder and elucidation of pathological significance in patients with chronic kidney disease: a prospective cohort study |
| Date of disclosure of the study information | 2021/10/15 |
| Last modified on | 2024/10/09 12:53:59 |
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Basic information
Public title
Early detection of asymptomatic cardiac reserve disorder and elucidation of pathological significance in patients with chronic kidney disease: a prospective cohort study
Acronym
Early detection of asymptomatic cardiac reserve disorder and elucidation of pathological significance in patients with chronic kidney disease
Scientific Title
Early detection of asymptomatic cardiac reserve disorder and elucidation of pathological significance in patients with chronic kidney disease: a prospective cohort study
Scientific Title:Acronym
Early detection of asymptomatic cardiac reserve disorder and elucidation of pathological significance in patients with chronic kidney disease
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study elucidates the causal relationship between asymptomatic cardiac reserve disorders and clinical outcomes in patients with chronic kidney disease.
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Elucidation of pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac reserve
Key secondary outcomes
Exercise tolerance
Physical function
Physical frailty
Social frailty
Protein-energy wasting
Physical activity
Cognitive function
Depression
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
patients with chronic kidney disease who are able to walk independently
Key exclusion criteria
Disagreement with test or study
Untreated heart disease
Contraindications to exercise testing
Target sample size
200
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
1250041
Address
1-35-8 Higashikanamachi, Katsushika-ku, Tokyo
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
1250041
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
Other
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、嬉泉クリニック(東京都)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 30 | Day |
Other
Other related information
This study will investigate the relationship between cardiac reserve and early impaired exercise tolerance, renal dysfunction, physical frailty, complications, and prognosis.
Management information
Registered date
| 2021 | Year | 10 | Month | 06 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052104
