UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of baroreflex function by novel noninvasive medical instruments in chronic heart failure patients and healthy subjects Pilot test
Title of the study (Brief title)	Pilot study for baroreflex evaluetion in CHF patients
Region	Japan

Condition
Condition	Chronic heart failure patients Healthy subjects
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

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	1
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	30

Research contact person
Name of lead principal investigator	Tomomi Ide
Organization	Kyushu University
Division name	Departments of Cardiovascular Medicine
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	Keita Saku
Organization	Kyushu University
Division name	Center for Disruptive Cardiovascular Medicine
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-6439
Homepage URL
Email	saku@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

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)

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	2018 Year 04 Month 26 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036927