UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014802
Receipt number R000017215
Scientific Title Usefulness of the autonomic nervous system evaluation by real-time heart rate variability analysis
Date of disclosure of the study information 2014/08/09
Last modified on 2018/08/13 11:46:58

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Basic information

Public title

Usefulness of the autonomic nervous system evaluation by real-time heart rate variability analysis

Acronym

Autonomic nervous system evaluation by real-time heart rate variability

Scientific Title

Usefulness of the autonomic nervous system evaluation by real-time heart rate variability analysis

Scientific Title:Acronym

Autonomic nervous system evaluation by real-time heart rate variability

Region

Japan


Condition

Condition

healthy Volunteer

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will evaluate the sympathetic activity by simultaneously performing for healthy volunteer "heart rate variability analysis method real-time" and the general analysis of muscle sympathetic nerve activity(MSNA).
Consequently, we can evaluate the autonomic nervous activity over time and instantaneous by the real-time heart rate variability analysis and demonstrate usefullness of its method.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the correlation between the number of times excitement and excitement frequency by (MSNA) muscle sympathetic and LF / HF rate of change by real-time heart rate variability analysis over time due to various stress or loads

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

evaluate the sympathetic nerve activity between MSNA and real-time heart rate valiability for healthy volinteer

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

participants (healthy volunteer), who could fully understand and agree all the contents of presenst study

Key exclusion criteria

Those whom the doctor or research investigator has determined to be inappropriate as a subject of the present study

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Tsutsui

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

Kita 15, Nishi 7, Kita-ku, Sapporo, Japan

TEL

011-706-6970

Email

htsutsui@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mamoru Sakakibara

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

Kita 15, Nishi 7, Kita-ku, Sapporo, Japan

TEL

011-706-6973

Homepage URL


Email

mike.s@ninus.ocn.ne.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 08 Month 09 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

recruited 8 paitients and analyize the data about autonomic nerve activity

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

2014 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 08 Month 09 Day

Last modified on

2018 Year 08 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017215


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name