UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046932 |
|---|---|
| Receipt number | R000053321 |
| Scientific Title | Multicenter Registry to EValuate risk factors for disEase progression, sudden cArdiac death and adverse cLinical outcomes in Japanese patients with Hypertrophic CardioMyopathy |
| Date of disclosure of the study information | 2022/02/17 |
| Last modified on | 2025/02/19 09:04:50 |
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Basic information
Public title
Multicenter Registry to EValuate risk factors for disEase progression, sudden cArdiac death and adverse cLinical outcomes in Japanese patients with Hypertrophic CardioMyopathy
Acronym
REVEAL-HCM
Scientific Title
Multicenter Registry to EValuate risk factors for disEase progression, sudden cArdiac death and adverse cLinical outcomes in Japanese patients with Hypertrophic CardioMyopathy
Scientific Title:Acronym
REVEAL-HCM
Region
| Japan |
Condition
Condition
Hypertrophic cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate actual managements of HCM in Japan and to develop novel prediction models for SCD and progression to dilated-phase
Basic objectives2
Others
Basic objectives -Others
To develop novel prediction models for SCD and progression to dilated-phase
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a) Sudden cardiac death and lethal ventricular arrhythmic events
b) progression to dilated-phase
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with HCM who meet (i) maximal LV wall thickness greater than or equal 15 mm, or (ii) maximal LV wall thickness greater than or equal 13 mm for patients with a first-degree relative with confirmed HCM
Key exclusion criteria
Patients who are judged as inappropriate for the enrollment.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Chisato |
| Middle name | |
| Last name | Izumi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Heart Failure and Transplantation
Zip code
564-8565
Address
6-1 Kishibe-Shinmachi, Suita, Osaka 564-8565, Japan
TEL
0661701070
izumi-ch@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Izumi |
Organization
National cerebral and cardiovascular center
Division name
Department of Heart Failure and Transplantation
Zip code
564-8565
Address
6-1 Kishibe-Shinmachi, Suita, Osaka 564-8565, Japan
TEL
0661701070
Homepage URL
izumi-ch@ncvc.go.jp
Sponsor or person
Institute
National cerebral and cardiovascular center
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center Research Ethics Committee
Address
6-1 Kishibe-Shinmachi, Suita, Osaka 564-8565, Japan
Tel
0661701070
rec-office-ac@ncvc.go.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
国立循環器病研究センター（大阪府）、京都大学医学部附属病院 （京都府）、九州大学病院（福岡県）、高知大学医学部附属病院（高知県）、大阪大学医学部附属病院（大阪府）、三重大学医学部附属病院（三重県）、日本医科大学付属病院 （東京都）、地方独立行政法人 神戸市民病院機構 神戸市立医療センター中央市民病院（兵庫県）、地方独立行政法人 大阪市民病院機構 大阪市立総合医療センター（大阪府）、独立行政法人 国立病院機構 大阪医療センター（大阪府）、公益財団法人 天理よろづ相談所病院（奈良県）、社会医療法人 社団十全会 心臓病センター榊原病院（岡山県）、一般財団法人 平成紫川会 小倉記念病院（福岡県）、公益財団法人大原記念倉敷中央医療機構 倉敷中央病院（岡山県）、公益財団法人田附興風会医学研究所 北野病院（大阪府）、医療法人渡辺医学会 桜橋渡辺病院（大阪府）、東北医科薬科大学病院（宮城県）、医療法人渓仁会 手稲渓仁会病院（北海道）、地方独立行政法人 桑名市総合医療センター（三重県）、地方独立行政法人 三重県立総合医療センター（三重県）、鈴鹿中央総合病院（三重県）、松阪中央総合病院（三重県）、伊勢赤十字病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 02 | Month | 17 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053321
