UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024407 |
|---|---|
| Receipt number | 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 | 2023/04/21 10:19:31 |
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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 | Hiroaki |
| Middle name | |
| Last name | Kitaoka |
Organization
Kochi Medical School, Kochi University
Division name
Department of Cardiology and Geriatrics
Zip code
783-8505
Address
Kohasu, Nankoku-chi, Kochi-ken, JAPAN
TEL
088-880-2352
kitaokah@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Minaguchi, Tabuchi |
| Middle name | |
| Last name | Minaguchi, Tabuchi |
Organization
Kochi Medical School Hospital
Division name
Kochi Medical School Hospital
Zip code
783-8505
Address
Kohasu, Nankoku-chi, Kochi-ken, JAPAN
TEL
088-880-2797
Homepage URL
http://www.kochi-ms.ac.jp/~fm_gratr/
rinri21@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi University
Institute
Department
Personal name
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
Kochi Medical School Hospital
Address
Kochi Medical School Hospital
Tel
08-880-2797
rinri21@kochi-u.ac.jp
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
1485
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028089
| Research Plan | |
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| 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 |
