UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036592 |
|---|---|
| Receipt number | 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 12:08:23 |
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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
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/
shouji-m@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Graduate School of Medical Science, Department of Cardiovascular Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041688
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
