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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008625
Receipt No. 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

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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
Email 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
Email takuya-t@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.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


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