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
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
| 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
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
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
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 |
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
