UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020629 |
|---|---|
| Receipt number | R000023811 |
| Scientific Title | Retrospective study of predicting tachycardia induced cardiomyopathy in heart failure with atrial tachyarrhythmia |
| Date of disclosure of the study information | 2016/01/19 |
| Last modified on | 2017/01/30 21:52:10 |
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Basic information
Public title
Retrospective study of predicting tachycardia induced cardiomyopathy in heart failure with atrial tachyarrhythmia
Acronym
Retrospective study of predicting tachycardia induced cardiomyopathy in heart failure with atrial tachyarrhythmia
Scientific Title
Retrospective study of predicting tachycardia induced cardiomyopathy in heart failure with atrial tachyarrhythmia
Scientific Title:Acronym
Retrospective study of predicting tachycardia induced cardiomyopathy in heart failure with atrial tachyarrhythmia
Region
| Japan |
Condition
Condition
Tachycardia induced cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the predictive factors for tachycardia induced cardiomyopathy in heart failure with atrial tachyarrhythmia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess predictive factors for tachycardia induced cardiomyopathy by cardiac magnetic resonance
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Heart failure patient with atrial fibrillation who is and outpatient/inpatient at National Cerebral and Cardiovascular Center
Key exclusion criteria
Patients with secondary cardiomyopathy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kengo Kusano |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka
TEL
06-6833-5012
kusanokengo@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kusano Kengo |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka
TEL
06-6833-5012
Homepage URL
kusanokengo@hotmail.com
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2016 | Year | 01 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/80/10/80_CJ-16-0532/_article
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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Inclusion criteria:Patients who were admitted and had cardiac magnetic resonance at National Cerebral and Cardiovascular Center between 2009 and 2014
Measurements:EF, EDV, ESV from cardiac magnetic resonance
Management information
Registered date
| 2016 | Year | 01 | Month | 19 | Day |
Last modified on
| 2017 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023811
