UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001723 |
|---|---|
| Receipt number | R000002074 |
| Scientific Title | Ehime Multicenter Registry for Evidence of Heart Failure |
| Date of disclosure of the study information | 2009/02/21 |
| Last modified on | 2009/08/25 14:59:35 |
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Basic information
Public title
Ehime Multicenter Registry for Evidence
of Heart Failure
Acronym
EMERGE-HF
Scientific Title
Ehime Multicenter Registry for Evidence
of Heart Failure
Scientific Title:Acronym
EMERGE-HF
Region
| Japan |
Condition
Condition
Chronic heart failue
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To eveluate the clinical characteristics and outcome of patients with chronic heart failure
Basic objectives2
Others
Basic objectives -Others
To identify significant prognostic biomarkers for heart failure
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac death and rehospitalization for worsening heart failure
Key secondary outcomes
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
The presence of heart failure which was confirmed by the simultaneous presence of at least 2 major criteria or 1 major criterion in conjunction with 2 minor criteria according to the Framingham criteria.
Key exclusion criteria
The presence of acute heart failure
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Okayama, MD and PhD |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Integrated Medicine and Informatics
Zip code
Address
Shitukawa, Toon, Ehime
TEL
089-960-5303
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Ohtsuka, MD and PhD |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Integrated Medicine and Informatics
Zip code
Address
Shitukawa, Toon, Ehime
TEL
089-960-5303
Homepage URL
https://ns.ehime-nh.go.jp/cgi-bin/emerge/emerge.cgi
tohtsuka@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Integrated Medicine and Informatics, Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
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
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
| 2009 | Year | 02 | Month | 21 | 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
Date of protocol fixation
| 2006 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
127 patients with heart failure have been entried.
Management information
Registered date
| 2009 | Year | 02 | Month | 21 | Day |
Last modified on
| 2009 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002074
| 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 |
