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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014105
Receipt No. 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

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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
Last 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
Email yuya8950@yahoo.co.jp

Public contact
1st 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
Email t-kitai@kcho.jp

Sponsor
Institute U-40 HF Network
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016232

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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