UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008625 |
|---|---|
| Receipt number | R000010134 |
| Scientific Title | Database Construction of Acute Decompensated Heart Failure Syndromes in Japan |
| Date of disclosure of the study information | 2012/08/05 |
| Last modified on | 2015/04/20 23:23:41 |
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Basic information
Public title
Database Construction of Acute Decompensated Heart Failure Syndromes in Japan
Acronym
Acute Heart Failure Syndromes Kyoto Registry
Scientific Title
Database Construction of Acute Decompensated Heart Failure Syndromes in Japan
Scientific Title:Acronym
Acute Heart Failure Syndromes Kyoto Registry
Region
| Japan |
Condition
Condition
Acute heart failure syndromes and acute decompensation of chronic heart failure
Classification by specialty
| Medicine in general | Cardiology | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate characteristics, clinical features, management of acute decompensated heart failure.
To identify crash and burn cases needed for ventricular assist device, cardiac regenerative medicine and heart transplant in acute decompensated heart failure syndromes.
Basic objectives2
Others
Basic objectives -Others
To clarify as follows;
1. patient characteristics and clinical features
2. states of management
3. in-hospital death and long-term clinical outcome after admission
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. diagnosis, patient characteristics, physical findings, blood chemistry examination
2. cardiac function
3. re-admission rate, in-hospital and long-term outcome (30 days, 180 days and further period)
Key secondary outcomes
1. ICD implantation for ventricular arrhythmia
2. cardiac surgery
3. hemorrhagic events
4. acute myocardial infarction
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive patients fulfilled by Framingham's criteria
1. acute heart failure
2. acute decompensation of chronic heart failure
Key exclusion criteria
patient without registration agreement
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Taniguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
465, Kajii-cho, Kamigyo-ku, Kyoto, Kyoto, Japan
TEL
075-251-5511
takuya-t@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Taniguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
465, Kajii-cho, Kamigyo-ku, Kyoto, Kyoto, Japan
TEL
075-251-5511
Homepage URL
takuya-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology; MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2012 | Year | 08 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
gender, age, body height and weight
diagnosis
patient characteristics (hypertension, diabetes mellitus, dyslipidemia, smoking, heart failure, arrhythmia, cerebral infarction, pulmonary disease, device, hemodialysis)
physical findings (symptoms, vital signs)
examination (blood chemistry, electrocardiogram, echocardiogram)
management (intravenous and oral agents, respiratory support, device, interventional therapy)
outcome/prognosis
Management information
Registered date
| 2012 | Year | 08 | Month | 05 | Day |
Last modified on
| 2015 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010134
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
