UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cardiopulmonary Exercise Testing Determination of Functional Capacity in Valve disease
Title of the study (Brief title)	Cardiopulmonary Exercise Testing Determination of Functional Capacity in Valve disease
Region	Japan

Condition
Condition	valve disease
Classification by specialty	Medicine in general Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to compare cardiac symptoms and the results of cardiopulmonary exercise test, and its prognostic value in patients with valvular heart disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cardiovascular events
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	mitral regurgitation aortic stenosis Left Ventricular Ejection Fractionis over 50%
Key exclusion criteria	LVEF is lower than 50% atrial fibrillation patients who can not ride a bike
Target sample size	70

Research contact person
Name of lead principal investigator	Masao Daimon
Organization	Juntendo University
Division name	Department of Cardiology
Address	2-1-1 Hongou Bunkyo-ku Tokyo Japan
TEL	0330133111
Email	daimon@muf.biglobe.ne.jp

Public contact
Name of contact person	Ryoko Ichikawa
Organization	Juntendo University
Division name	Department of Cardiology
Address	2-1-1 Hongou Bunkyo-ku Tokyo Japan
TEL	03-3813-3111
Homepage URL
Email	richikaw@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
Organization
Division
Category of Funding Organization	Other
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	2011 Year 10 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 01 Day
Anticipated trial start date	2011 Year 10 Month 05 Day
Last follow-up date
Date of closure to data entry	2014 Year 10 Month 01 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We will perform cardiopulmonary exercise test on valve disease patients and comare their symptoms with functional capacity. Then we will observe cardiac events and prognosis.

Management information
Registered date	2011 Year 10 Month 05 Day
Last modified on	2018 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007688