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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024407
Receipt No. R000028089
Scientific Title A national registration survey of patients with hypertrophic cardiomyopathy in Japan
Date of disclosure of the study information 2016/10/14
Last modified on 2018/04/21

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Basic information
Public title A national registration survey of patients with hypertrophic cardiomyopathy in Japan
Acronym J-HCM Study
Scientific Title A national registration survey of patients with hypertrophic cardiomyopathy in Japan
Scientific Title:Acronym J-HCM Study
Region
Japan

Condition
Condition Hypertrophic cardiomyopathy
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate prognostic factors in patients with hypertrophic cardiomyopathy
Basic objectives2 Others
Basic objectives -Others Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To elucidate prognostic factors in patients with hypertrophic cardiomyopathy
Key secondary outcomes To evaluate the natural history and clinical course through the treatment in patients with hypertrophic cardiomyopathy

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 Hypertrophic cardiomyopathy (Patients with unexplained left ventricular hypertrophy, i.e., maximum left ventricular wall thickness more than or equal to 15 mm)
Key exclusion criteria None
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Kitaoka, MD
Organization Kochi Medical School, Kochi University
Division name Department of Cardiology and Geriatrics
Zip code
Address Kohasu, Nankoku-chi, Kochi-ken, JAPAN
TEL 088-880-2352
Email kitaokah@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eguchi, Tsuzuki
Organization Kochi Medical School Hospital
Division name Kochi Medical School Hospital
Zip code
Address Kohasu, Nankoku-chi, Kochi-ken, JAPAN
TEL 088-880-2352
Homepage URL http://www.kochi-ms.ac.jp/~fm_gratr/
Email rinri21@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School, Kochi University

Institute
Department

Funding Source
Organization MSD K.K., Bayer Yakuhin Ltd, Pfizer Japan Inc
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 北海道大学病院(Hokkaido University Hospital)(北海道)
札幌心臓血管クリニック(Sapporo Cardiovascular Center)(北海道)
仙台厚生病院(Sendai Kousei Hospital)(宮城県)
金沢大学病院(Kanazawa University Hospital)(石川県)
北里大学病院(Kitasato University Hospital)(神奈川県)
昭和大学藤が丘病院(Showa University Fujigaoka Hospital)(神奈川県)
慶應義塾大学病院(Keio University Hospital)(東京都)
榊原記念病院(Sakakibara Heart Institute)(東京都)
東京医科大学病院(Tokyo Medical University Hospital)(東京都)
東京医科歯科大学医学部附属病院(Medical Hospital, Tokyo Medical and Dental University)(東京都)
東京女子医科大学病院(Tokyo Women’s Medical University Hospital)(東京都)
日本医科大学付属病院(Nippon Medical School Hospital)(東京都)
浜松医科大学医学部附属病院(Hamamatsu University Hospital)(静岡県)
藤田保健衛生大学病院(Fujita Health University Hospital)(愛知県)
大阪医科大学附属病院(Osaka Medical College Hospital)(大阪府)
京都大学医学部附属病院(Kyoto University Hospital)(京都府)
大阪市立大学医学部附属病院(Osaka City Universal Hospital)(大阪府)
三重大学医学部附属病院(Mie Universal Hospital)(三重県)
愛媛大学附属病院(Ehime University Hospital)(愛媛県)
熊本大学医学部附属病院(Kumamoto University Hospital)(熊本県)
鹿児島大学病院(Kogoshima University Hospital)(鹿児島県)
市立宇和島病院(Uwajima City Hospital)(愛媛県)
近森病院(Chikamori Hospital)(高知県)
高知大学医学部附属病院(Kochi Medical School Hospital)(高知県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 14 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
2016 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study to elucidate prognostic factors in patients with hypertrophic cardiomyopathy

Management information
Registered date
2016 Year 10 Month 14 Day
Last modified on
2018 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028089

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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