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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034309
Receipt No. R000039114
Scientific Title The study of the relationship between vasovagal reflex and heart rate variability in cardiopulmonary exercise test
Date of disclosure of the study information 2018/11/01
Last modified on 2019/03/31

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Basic information
Public title The study of the relationship between vasovagal reflex and heart rate variability in cardiopulmonary exercise test
Acronym The study of the relationship between vasovagal reflex and HRV in CPX
Scientific Title The study of the relationship between vasovagal reflex and heart rate variability in cardiopulmonary exercise test
Scientific Title:Acronym The study of the relationship between vasovagal reflex and HRV in CPX
Region
Japan

Condition
Condition patients undergoing cardiorespiratory exercise test
Classification by specialty
Cardiology Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Cardiopulmonary exercise test is an essential test for deciding appropriate load in cardiac rehabilitation. Even in healthy subjects, vascular vagus nerve reflex may occur upon examination. In order to prevent this symptom, cool down is done after the load, but symptoms of vasovagal syncope are observed at a certain rate. The purpose of this study is to predict the development of vasovagal reflex in cardiopulmonary exercise tolerance test by evaluation of vagus nerve function using heart rate variability.
Basic objectives2 Others
Basic objectives -Others If we can evaluate the risk of vasovagal syncope in advance, we believe that risks associated with lowering blood pressure and syncope can be avoided.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes occurrence of vasovagal syncope
Key secondary outcomes

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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing cardiorespiratory exercise test
Key exclusion criteria Inappropriate person for cardiopulmonary exercise test
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Jyunichi
Middle name
Last name Tomono
Organization Gunma University Hospital
Division name Rehabilitation Medicine
Zip code 371-8511
Address 3-39-22, Showamachi, Maebashi, Gunma, Japan
TEL 027-220-8655
Email jun.tomono@gmail.com

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Wada
Organization Gunma University Hospital
Division name Rehabilitation Medicine
Zip code 371-8511
Address 3-39-22, Showamachi, Maebashi, Gunma, Japan
TEL 027-220-8655
Homepage URL http://ciru.dept.showa.gunma-u.ac.jp
Email nwada@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University
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 Clinical Investigation and Research Unit
Address 3-39-22, Showamachi, Maebashi, Gunma, Japan
Tel 027-220-8740
Email hitotaisho-ciru@ml.gunma-u.ac.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 群馬大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 01 Day

Related information
URL releasing protocol http://ciru.dept.showa.gunma-u.ac.jp/guidance/storage-sample/list.html
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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information Examination of occurrence of vasovagal reflex and predictive factors in cardiorespiratory exercise test

Management information
Registered date
2018 Year 09 Month 28 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039114

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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