UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of cardiopulmonary functional improvement after cardiac surgery using the inert gas rebreathing method
Title of the study (Brief title)	Assessment of cardiopulmonary functional improvement after cardiac surgery using the inert gas rebreathing method
Region	Japan

Condition
Condition	Mitral valve regurgitation
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to assess what factors influence the cardiopulmonary function in response to maximum exercise after cardiac surgery.
Basic objectives2	Others
Basic objectives -Others	The cardiac surgery does not always improve the patients overall cardiopulmonary function even 6 months after surgery. Not only cardiac function but also pulmonary or skeletal muscular function influences the results of the ordinarily cardiopulmonary exercise test. Although cardiac output is one of the key indices of cardiac function, it is usually difficult to measure during exercise. In this study, we plan to measure cardiac output in response to maximum exercise after cardiac surgery using the inert gas rebreathing method.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	1) Cardiac output during exercise using the inert gas rebreathing method 2) Mean mitral valve pressure gradient during exercise 3) Peak VO2 derived from cardiopulmonary exercise test
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Patients who undergo mitral valve repair for degenerative disease. Following cardiac/pulmonary/skeletal muscular assessment were performed pre- and post (2 weeks, 3 months, 6 months, 12 months) surgery. 1) Cardiac output measurement using inert gas rebreathing method 2) Exercise stress echocardiography 3) Cardiopulmonary exercise test 4) Spirometry 5) Skeletal muscular strength, thigh/calf circumference measurement
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who undergo mitral valve repair for degenerative disease. 2) Patients who can perform bicycle ergometer test
Key exclusion criteria	1) Patients who is in atrial fibrillation 2) Patients who has more than moderate residual mitral regurgitation
Target sample size	20

Research contact person
Name of lead principal investigator	Hitoshi Yaku
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Cardiovascular surgery
Address	465 Kajii-cho, Kamigyo-ku, Kyoto
TEL	075-251-5752
Email	yakuh@koto.kpu-m.ac.jp

Public contact
Name of contact person	Kiyoshi Doi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Cardiovascular surgery
Address	465 Kajii-cho, Kamigyo-ku, Kyoto
TEL	075-251-5752
Homepage URL
Email	kdoi@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine Department of Cardiovascular Surgery
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	2015 Year 08 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 04 Month 12 Day
Anticipated trial start date	2015 Year 09 Month 01 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	2015 Year 04 Month 12 Day
Last modified on	2017 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019849