UMIN-CTR Clinical Trial

Basic information
Public title	High-precision prediction of adverse outcomes and development of optimal therapeutic strategy in heart failure
Acronym	The Japanese Registry of Acute Decompensated Heart Failure-NEXT
Scientific Title	High-precision prediction of adverse outcomes and development of optimal therapeutic strategy in heart failure
Scientific Title:Acronym	The Japanese Registry of Acute Decompensated Heart Failure-NEXT
Region	Japan

Condition
Condition	Acute heart failure / Chronic heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To investigate prognostic factors of developing or exacerbation of heart failure
Basic objectives2	Others
Basic objectives -Others	To validate the prognostic score mentioned above, and find effective treatment strategy
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Death (Cardiovascular death, Non-cardiovascular death) Cardiovascular readmission ( heart failure, myocardial infarction, stroke, others) Heart failure readmission
Key secondary outcomes	Readmission (Any cause) Change in NYHA class Change in BNP QOL(KCCQ)

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.Patients who are hospitalized primarily due to acute decompensated heart failure requiring treatment 2.Heart failure is diagnosed besed on Framingham criteria in Japanese Circulation Society guideline, and BNP >=100pg/ml or NT-proBNP>=300pg/ml 3.Patients older than 20 years old 4.Patients who give written consent
Key exclusion criteria	1.Patients who have had heart transplantation 2.Patients who had acute coronary syndrome requiring emergent coronary revascularization 3.Patients judged to be inappropriate to perform this study by investigator
Target sample size	5000

Research contact person
Last name of lead principal investigator	1st name Hiroyuki Middle name Last name Tsutsui
Organization	Kyushu University Graduate School of Medical Science
Division name	Department of Cardiovascular Medicine
Zip code	812-858
Address	3-1-1 Maidashi Higashi-ku Fukuoka, Japan
TEL	092-642-5357
Email	htsutsui@cardiol.med.kyushu-u.ac.jp

Public contact
1st name of contact person	1st name Shouji Middle name Last name Matsushima
Organization	Kyushu University Graduate School of Medical Science
Division name	Department of Cardiovascular Medicine
Zip code	812-8582
Address	3-1-1 Maidashi Higashi-ku Fukuoka, Japan
TEL	092-642-5360
Homepage URL	https://www.jroadhf-next.jp/
Email	shouji-m@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Graduate School of Medical Science, Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu University Ethical Review Committe
Address	3-1-1 Maidashi Higashi-ku Fukuoka, Japan
Tel	092-642-5774
Email	ijkseimei@jimu.kyushu-u.ac.jp

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	2019 Year 04 Month 25 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	Enrolling by invitation
Date of protocol fixation	2019 Year 04 Month 01 Day
Date of IRB	2019 Year 04 Month 15 Day
Anticipated trial start date	2019 Year 04 Month 15 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective observational study

Management information
Registered date	2019 Year 04 Month 24 Day
Last modified on	2019 Year 05 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041688