UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018571 |
|---|---|
| Receipt number | R000021497 |
| Scientific Title | A multi-center observational study of dilated phase of hypertrophic cardiomyopathy |
| Date of disclosure of the study information | 2015/08/06 |
| Last modified on | 2017/02/06 11:08:42 |
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Basic information
Public title
A multi-center observational study of dilated phase of hypertrophic cardiomyopathy
Acronym
A multi-center observational study of dilated phase of hypertrophic cardiomyopathy
Scientific Title
A multi-center observational study of dilated phase of hypertrophic cardiomyopathy
Scientific Title:Acronym
A multi-center observational study of dilated phase of hypertrophic cardiomyopathy
Region
| Japan |
Condition
Condition
Dilated phase of hypertrophic cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate prevalence and prognosis of dilated phase of hypertrophic cardiomyopathy
Basic objectives2
Others
Basic objectives -Others
To elucidate severity and prognostic factor of dilated phase of hypertrophic cardiomyopathy
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiovascular event
Observational period until cardiovascular event
Key secondary outcomes
Survival rate
BNP
Echocardiography
NYHA functional class
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients that have been diagnosed as dilated phase of cardiomyopathy (wall thickness >=15mm in echocardiography) and left ventricular dysfunction (left ventricular ejection fraction < 50%)
Key exclusion criteria
Patients judged to be inappropriate to perform this study by investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsutsui |
Organization
Kyushu University Graduate School of Medical Science
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka, Japan
TEL
092-642-5357
htsutsui@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shouji Matsushima |
Organization
Kyushu University Graduate School of Medical Science
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka, Japan
TEL
092-642-5357
Homepage URL
shouji-m@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Hiroyuki Tsutsui
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
Japan
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
北海道大学（北海道）、山形大学（山形県）、東北大学（宮城県）、東京大学（東京都）、東京医科歯科大学（東京都）、名古屋大学（愛知県）、金沢大学（石川県）、国立循環器病センター（大阪府）、福島県立医科大学（福島県）、東京慈恵会医科大学（東京都）、奈良県立医科大学（奈良県）、九州大学（福岡県）、慶應義塾大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2015 | Year | 08 | Month | 06 | Day |
Last modified on
| 2017 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021497
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
