UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003887
Receipt number R000004679
Scientific Title Effects of an increase and a decrease in cardiac filling pressure on muscle and skin sympathetic nerve activity during passive warming in humans
Date of disclosure of the study information 2014/07/08
Last modified on 2018/06/21 17:06:04

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Basic information

Public title

Effects of an increase and a decrease in cardiac filling pressure on muscle and skin sympathetic nerve activity during passive warming in humans

Acronym

Muscle and skin sympathetic nerve activity during Valsalva's maneuver or continuous negative-pressure breathing

Scientific Title

Effects of an increase and a decrease in cardiac filling pressure on muscle and skin sympathetic nerve activity during passive warming in humans

Scientific Title:Acronym

Muscle and skin sympathetic nerve activity during Valsalva's maneuver or continuous negative-pressure breathing

Region

Japan


Condition

Condition

Heat stroke

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is well-known that an incarese or decrease in venous return to the heart due to an increase or decease in blood volume enhances or reduces cutaneous vasodilation in hyperthermic humans. The purpose of our study is to identify an efferent pathway for controlling skin blood flow.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skin sympathetic nerve activity and skin blood flow during Valsalva's maneuver and continuos negative-pressure breathing.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Passive heating
Valsalva's maneuver
Continuos negative-pressure breathing

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

35 years-old >=

Gender

Male

Key inclusion criteria

Male subjects who desire to participate by voluntary agreement.

Key exclusion criteria

#1. History of hepatic, thyroid, renal, metabolic, cardiovascular, or pulmonary diseases.
#2. To take any medicines regularly.
#3. History of smoking within a year.
#4. Abnormal ECG
#5. Sytolic or diastolic blood pressures over 130 mmHg or 85 mmHg
#6. Persons who should be excluded from the present study by doctor's judgement.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Nose

Organization

Shinshu University Graduate School of Medicine

Division name

Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention

Zip code


Address

Asahi 3-1-1, matsumoto, Japan

TEL

0263-37-2681

Email

nosehir@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshi-ichiro Kamijo

Organization

Shinshu University Graduate School of Medicine

Division name

Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

0263-37-2682

Homepage URL


Email

yoshikmj@shinshu-u.ac.jp


Sponsor or person

Institute

Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention, Shinshu University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

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 07 Month 08 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2010 Year 07 Month 05 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 05 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

2010 Year 07 Month 08 Day

Last modified on

2018 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004679


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name