UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Registry focused on very early presentation and treatment in emergency department of acute heart failure syndrome
Title of the study (Brief title)	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	Yuya Matsue
Organization	Kameda Medical Center
Division name	Department of Cardiology
Address	929, Higashi-Cho, Kamogawa, Chiba
TEL	047-092-2211
Email	yuya8950@yahoo.co.jp

Public contact
Name of contact person	Takeshi Kitai
Organization	Kobe City Medical Center General Hospital
Division name	Department of Cardiology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 06 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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