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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036263
Receipt No. 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 2019/03/19

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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
Email 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
Email yoshitatsu.f@gmail.com

Sponsor
Institute Asahi University Hospital
Institute
Department

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
Email 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 Open public recruiting
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
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 19 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041121

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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