UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000032379
Receipt number	R000036927
Scientific Title	Evaluation of baroreflex function by novel noninvasive medical instruments in chronic heart failure patients and healthy subjects Pilot test
Date of disclosure of the study information	2018/04/26
Last modified on	2018/08/07 15:27:15

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Basic information

Public title

Evaluation of baroreflex function by novel noninvasive medical instruments in chronic heart failure patients and healthy subjects Pilot test

Acronym

Pilot study for baroreflex evaluetion in CHF patients

Scientific Title

Evaluation of baroreflex function by novel noninvasive medical instruments in chronic heart failure patients and healthy subjects Pilot test

Scientific Title:Acronym

Pilot study for baroreflex evaluetion in CHF patients

Region

Japan

Condition

Chronic heart failure patients
Healthy subjects

Classification by specialty

Cardiology Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Evaluation of baroreflex function from arterial pressure waveform obtained with novel noninvasive device in chronic heart failure patients and healthy subjects.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Baroreflex function evaluate from arterial waveform

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Use of unapproved equipment (wrist type continuous blood pressure monitor) 30 minutes once

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

Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy subjects
Age is 20 years or older at the time of acquiring consent
Who have not been diagnosed heart failure and arrhythmia in the past half year and who have not undergone regular medical treatment
Who got document agreement by voluntary free will after fully understanding after participating in this exam

For patients with chronic heart failure,
Age is 20 years or older at the time of acquiring consent
Patients with chronic heart failure (those with a left ventricular contractility of less than 50% in transthoracic echocardiography)
A person equivalent to I to II degrees in NYHA classification
Persons who have no history of hospitalization in the past 3 months and have stable disease condition
Person who got document agreement by voluntary free will after fully understanding after participating in this exam

Key exclusion criteria

Those who satisfy one of the following items are excluded.
Atrial fibrillation
Poor control diabetes (HbA1c> 7%)
Undergoing pacemaker implantation for arrhythmia
Epilepsy
During pregnancy, breast-feeding, who may be pregnant
Under dialysis
Skin trouble on upper arm and wrist, who can not measure blood pressure
Judged inappropriate by the examining physician
Others who are difficult to complete this test protocol

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Tomomi Ide

Organization

Kyushu University

Division name

Departments of Cardiovascular Medicine

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

092-642-6439

Email

tomomi_i@cardiol.med.kyushu-u.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Keita Saku

Organization

Kyushu University

Division name

Center for Disruptive Cardiovascular Medicine

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

092-642-6439

Homepage URL

Email

saku@cardiol.med.kyushu-u.ac.jp

Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name

Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 26 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 03 Month 27 Day

Date of IRB

Anticipated trial start date

2018 Year 05 Month 02 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

2018 Year 04 Month 25 Day

Last modified on

2018 Year 08 Month 07 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036927

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name