UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006480 |
|---|---|
| Receipt number | R000007688 |
| Scientific Title | Cardiopulmonary Exercise Testing Determination of Functional Capacity in Valve disease |
| Date of disclosure of the study information | 2011/10/05 |
| Last modified on | 2018/04/10 19:56:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Cardiopulmonary Exercise Testing Determination of Functional Capacity in Valve disease
Acronym
Cardiopulmonary Exercise Testing Determination of Functional Capacity in Valve disease
Scientific Title
Cardiopulmonary Exercise Testing Determination of Functional Capacity in Valve disease
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masao Daimon |
Organization
Juntendo University
Division name
Department of Cardiology
Zip code
Address
2-1-1 Hongou Bunkyo-ku Tokyo Japan
TEL
0330133111
daimon@muf.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoko Ichikawa |
Organization
Juntendo University
Division name
Department of Cardiology
Zip code
Address
2-1-1 Hongou Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
Homepage URL
richikaw@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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)
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
| 2011 | Year | 10 | Month | 05 | 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
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007688
