UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018008 |
|---|---|
| Receipt number | R000020867 |
| Scientific Title | Current status of primary prevention of sudden cardiac death with implantable cardioverter defibrillator in patients with chronic heart failure:a report from the CHART-2 Study |
| Date of disclosure of the study information | 2015/06/22 |
| Last modified on | 2015/06/22 14:52:09 |
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Basic information
Public title
Current status of primary prevention of sudden cardiac death with implantable cardioverter defibrillator in patients with chronic heart failure:a report from the CHART-2 Study
Acronym
CHART-2 Study: Prevention of sudden cardiac death with ICD
Scientific Title
Current status of primary prevention of sudden cardiac death with implantable cardioverter defibrillator in patients with chronic heart failure:a report from the CHART-2 Study
Scientific Title:Acronym
CHART-2 Study: Prevention of sudden cardiac death with ICD
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the benefit of implantable cardioverter defibrillator for primary prevention of sudden cardiac death.
Basic objectives2
Others
Basic objectives -Others
To examine the benefit of implantable cardioverter defibrillator for primary prevention of sudden cardiac death.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fatal arrhythmic events
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Additional Blood Sampling(5mL)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
NYHA class II-III
Key exclusion criteria
IHD or NIDCM
Prior VT
ICD for secondary prevention
Target sample size
2778
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Shimokawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi,Aoba-ku,Sendai,Japan
TEL
+81-22-717-7153
shimo@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Sakata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi,Aoba-ku,Sendai,Japan
TEL
+81-22-717-7153
Homepage URL
sakatayk@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine Department of Cardiovascular Medicine
Tohoku heart Failure Association
Evidence-based Cardiovascular Medicine Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Evidence-based Cardiovascular Medicine Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2006 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | 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
Management information
Registered date
| 2015 | Year | 06 | Month | 22 | Day |
Last modified on
| 2015 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020867
