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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018571
Receipt No. 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

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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
Email 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
Email shouji-m@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute Hiroyuki Tsutsui
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021497

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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