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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036592
Receipt No. R000041688
Scientific Title High-precision prediction of adverse outcomes and development of optimal therapeutic strategy in heart failure
Date of disclosure of the study information 2019/04/25
Last modified on 2019/05/03

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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
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
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

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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