UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051757 |
|---|---|
| Receipt number | R000059069 |
| Scientific Title | Japanese registry of primary prevention implantable cardioverter defibrillator in heart failure patients |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2024/01/30 09:31:38 |
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Basic information
Public title
Japanese registry of primary prevention implantable cardioverter defibrillator in heart failure patients
Acronym
J-Prime ICD
Scientific Title
Japanese registry of primary prevention implantable cardioverter defibrillator in heart failure patients
Scientific Title:Acronym
J-Prime ICD
Region
| Japan |
Condition
Condition
Heart failure patients with primary prevention implantable cardioverter defibrillator
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates pharmacological and non-pharmaceutical treatments for heart failure patients with an ICD implanted for exploring appropriate ICD indication.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between pharmacological and non-pharmacological treatments and incidence of arrhythmia
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Heart failure patients with primary prevention implantable cardioverter defibrillator
Key exclusion criteria
HCM, ARVC, Brugada/LQT/idiopathic VF
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Morio |
| Middle name | |
| Last name | Shoda |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiology
Zip code
162-8666
Address
kawada-cho 8-1, shinjuku-ku, Tokyo
TEL
03-3353-8111
suzuki.atsushi@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiology
Zip code
162-8666
Address
kawada-cho 8-1, shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
suzuki.atsushi@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University
Address
kawada-cho 8-1, shinjuku-ku, Tokyo
Tel
03-3353-8111
carp-info.bm@twmu.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2023 | Year | 07 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059069
| 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 |
