UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036263 |
|---|---|
| Receipt number | R000041121 |
| Scientific Title | Changes in renal blood flow with low load and moderate load in heart failure patients |
| Date of disclosure of the study information | 2019/03/20 |
| Last modified on | 2022/02/25 16:29:13 |
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Basic information
Public title
Changes in renal blood flow with low load and moderate load in heart failure patients
Acronym
Changes in renal blood flow with low load and moderate load in heart failure patients
Scientific Title
Changes in renal blood flow with low load and moderate load in heart failure patients
Scientific Title:Acronym
Changes in renal blood flow with low load and moderate load in heart failure patients
Region
| Japan |
Condition
Condition
Heart failure patients
Classification by specialty
| Medicine in general | Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Changes of renal blood flow to exercise intensity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Absolute and relative change of exercise-related renal blood flow, cardiopulmonary exercise test using ultrasonic inspection equipment
Key secondary outcomes
Cardiac function, blood pressure, heart rate,Renal function, blood test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
low load to moderate load
Interventions/Control_2
moderate load to low load
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
Heart failure patients
Key exclusion criteria
patients who is contraindication of exercise therapy
patients who is contraindication for cardiopulmonary exercise test
dialysis patients
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshitatsu |
| Middle name | |
| Last name | Fukuta |
Organization
Asahi University Hospital
Division name
rehabilitation
Zip code
5008523
Address
3-23 Hashimoto,Gifu,Gifu 501-8856 Japan
TEL
058-253-8734
yoshitatsu.f@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitatsu |
| Middle name | |
| Last name | Fukuta |
Organization
Asahi University Hospital
Division name
rehabilitation
Zip code
5008523
Address
3-23 Hashimoto,Gifu,Gifu 501-8856 Japan
TEL
058-253-8734
Homepage URL
yoshitatsu.f@gmail.com
Sponsor or person
Institute
Asahi University Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi University 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
Asahi University Hospital
Address
rehabilitation
Tel
058-253-8734
yoshitatsu.f@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
| 2019 | Year | 03 | Month | 20 | 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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 19 | Day |
Last modified on
| 2022 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041121
