UMIN-CTR Clinical Trial

Basic information
Public title	Dynamic Changes in Mitral Valve Geometry During Hand Grip Exercise and Its Association With Exercise Induced Mitral Regurgitation A Real Time 3 Dimentional Transesophageal Echocardiography Study
Acronym	Dynamic Changes in Mitral Valve Geometry During Hand Grip Exercise and Its Association With Exercise
Scientific Title	Dynamic Changes in Mitral Valve Geometry During Hand Grip Exercise and Its Association With Exercise Induced Mitral Regurgitation A Real Time 3 Dimentional Transesophageal Echocardiography Study
Scientific Title:Acronym	Dynamic Changes in Mitral Valve Geometry During Hand Grip Exercise and Its Association With Exercise
Region	Japan

Condition
Condition	Mitral regurgitation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this 3D-TEE study is to define a relationship between the dynamic changes in mitral valve geometry during hand-grip exercise and exercise induced mitral regurgitation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes of mitral rigurgitation during hand-grip exercise
Key secondary outcomes	Geometric changes in the mitral valve complex Hemodynamic parameters exercise tolerability

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Hand-grip exercise
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	Written informed consent is obtained from the patients Patients with more than 20 years old Patients who has more than moderate mitral regurgitation
Key exclusion criteria	The patients who can not load hand grip The patients with more than moderate valvular disease other than mitral regurgitation The patients who underwent valvular disease surgery The patients with unstable hemodynamic state The patients who were found unfit to be respondent to a survey by physician incharge
Target sample size	80

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroto Utsunomiya
Organization	Hiroshima University
Division name	Department of Cardiovascular Medicine, Graduate School of Biomedical & Health Sciences
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5540
Email	hiroto.utsu@gmail.com

Public contact
1st name of contact person	1st name Middle name Last name Yu Harada
Organization	Hiroshima University
Division name	Department of crdiovascular Medicine, Graduate School of Biomedical & Health Sciences
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5540
Homepage URL
Email	dokkyotakiguchi@yahoo.co.jp

Sponsor
Institute	Department of crdiovascular Medicine, Graduate School of Biomedical & Health Sciences,Hiroshima University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2017 Year 06 Month 28 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	Completed
Date of protocol fixation	2017 Year 06 Month 28 Day
Date of IRB	2017 Year 06 Month 23 Day
Anticipated trial start date	2017 Year 06 Month 28 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 28 Day
Last modified on	2019 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031995