UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017024 |
|---|---|
| Receipt number | R000019743 |
| Scientific Title | Establishment of in-hospital registry database and practical use of the data for the risk stratification and the assessment of treatment strategies in acute cardiovascular care |
| Date of disclosure of the study information | 2015/04/03 |
| Last modified on | 2024/05/02 09:14:08 |
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Basic information
Public title
Establishment of in-hospital registry database and practical use of the data for the risk stratification and the assessment of treatment strategies in acute cardiovascular care
Acronym
A registry database for acute decompensated heart failure (National cerebral and cardiovascular center acute DEcompensated heart Failure Study:NaDEF Study)
Scientific Title
Establishment of in-hospital registry database and practical use of the data for the risk stratification and the assessment of treatment strategies in acute cardiovascular care
Scientific Title:Acronym
A registry database for acute decompensated heart failure (National cerebral and cardiovascular center acute DEcompensated heart Failure Study:NaDEF Study)
Region
| Japan |
Condition
Condition
Acute decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the quality of medicine and clinical outcomes in acute heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Death
2. Worsening heart failure
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
Emergency admission due to acute decompensated heart failure
Key exclusion criteria
Acute coronary syndrome
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihisa Anzai |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
Address
5-7-1, Fujishiro-dai, Suita, Osaka
TEL
06-6833-5012
anzai@ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nagai |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
Address
5-7-1, Fujishiro-dai, Suita, Osaka
TEL
06-6833-5012
Homepage URL
nagai@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
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 | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2010 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2015 | Year | 04 | Month | 02 | Day |
Last modified on
| 2024 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019743
