UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034309
Receipt number 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 2021/03/31 17:54:23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Gunma University

Institute

Department

Personal name



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

Published


Result

URL related to results and publications

https://www.jisprm.org/article.asp?issn=2349-7904;year=2020;volume=3;issue=5;spage=1;epage=488;aulas

Number of participants that the trial has enrolled

76

Results

Fifteen (19.7%) patients had VS during or in the first 5 min after CPX. Seven (9%) patients had symptomatic VS. In the spectral analysis of HRV, significant differences in the normalized low frequency unit (nLF) and normalized high frequency unit (nHF) values were recognized between the two groups. A logistic model identified a significant association between the LF/HF ratio and the occurrence of VS.

Results date posted

2021 Year 03 Month 31 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

We evaluated 76 subjects of 20 to 80 years of age who underwent a CPX in our hospital.

Participant flow

An analysis of HRV was performed 5 min before the CPX with the subject at rest using a portable electrocardiograph. The patients heart rate and blood pressure were continuously recorded during the CPX. VS was defined by symptomatic syncope or a 20 mmHg decrease in systolic blood pressure from the baseline value. Subjects were divided into two groups according to the occurrence of VS during CPX. An autoregressive model was used for the spectral analysis of HRV.

Adverse events

No adverse events

Outcome measures

Symptomatic syncope or a 20 mmHg decrease in systolic blood pressure from the baseline value.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 11 Month 01 Day

Date of IRB

2018 Year 11 Month 05 Day

Anticipated trial start date

2018 Year 11 Month 05 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

2021 Year 03 Month 31 Day



Link to view the page

Value
https://center6.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