UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014105 |
|---|---|
| Receipt number | R000016232 |
| Scientific Title | Registry focused on very early presentation and treatment in emergency department of acute heart failure syndrome |
| Date of disclosure of the study information | 2014/05/30 |
| Last modified on | 2019/01/14 01:38:21 |
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Basic information
Public title
Registry focused on very early presentation and treatment in emergency department of acute heart failure syndrome
Acronym
REALITY-AHF
Scientific Title
Registry focused on very early presentation and treatment in emergency department of acute heart failure syndrome
Scientific Title:Acronym
REALITY-AHF
Region
| Japan |
Condition
Condition
Acute Heart Failure Syndrome
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current state of super-acute phase treatment for acute heart failure syndrome (AHFS) including in emergency department (ED) and it's effect on prognosis .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Combined endpoint of all cause mortality and readmission due to heart failure within 1 year.
Key secondary outcomes
In-hospital death; all cause mortality within 30 days/90 days/1 year after discharge; heart failure readmission rate within 30 days/90 days/1 year after discharge.
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
1. AHFS patients who are admitted via emergency department.
2. The AHFS is diagnosed according to Framingham criteria.
3. Over 20 years old.
4. AHFS was diagnosed within 3 hours after arriving to ED and physical exam was taken by medical staff.
Key exclusion criteria
1. After cardiac transplantation
2. Chronic hemodialysis
3. Acute myocarditis
4. Acute coronary syndrome require emergent revascularization
5. BNP level < 100 pg/mL or N-terminal-proBNP level < 300 pg/mL at baseline
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuya Matsue |
Organization
Kameda Medical Center
Division name
Department of Cardiology
Zip code
Address
929, Higashi-Cho, Kamogawa, Chiba
TEL
047-092-2211
yuya8950@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Kitai |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Cardiology
Zip code
Address
2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
TEL
078-302-4321
Homepage URL
t-kitai@kcho.jp
Sponsor or person
Institute
U-40 HF Network
Institute
Department
Personal name
Funding Source
Organization
The Cardiovascular Research Fund, Tokyo, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
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
亀田メディカルセンター（千葉）・神戸市立医療センター中央市民病院（兵庫）・聖路加国際病院（東京）・聖マリアンナ医科大学（神奈川)・北里大学（神奈川）・東京医科大学茨城医療センター（茨城）・東京医科歯科大学（東京）・福島県立医科大学（福島）・筑波大学（茨城）・横浜市立大学附属市民総合医療センター（神奈川）・日本医科大学（東京）・日本医科大学武蔵小杉病院（神奈川）・名古屋大学（愛知）・関西労災病院（大阪）・西宮渡辺心臓血管センター（大阪）・心臓病センター榊原病院（岡山）・兵庫県立姫路循環器病センター（兵庫）・神戸百年記念病院（兵庫）・武蔵野赤十字病院（東京）・済生会福岡総合病院（福岡）・高知大学（高知）・滋賀県立成人病センター（滋賀）・赤穂市民病院（兵庫）・豊見城中央病院（沖縄）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 30 | 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
| 2014 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Elucidate the correlation between therapy for AHFS in acute phase and prognosis by prospective multicenter registry in Japan.
Management information
Registered date
| 2014 | Year | 05 | Month | 29 | Day |
Last modified on
| 2019 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016232
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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