UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010161 |
|---|---|
| Receipt number | R000011899 |
| Scientific Title | Observational cohort study of acute heart failure in Yokohama, Yokohama Acute Heart Failure (YAHF) registry |
| Date of disclosure of the study information | 2013/03/05 |
| Last modified on | 2014/11/05 08:10:46 |
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Basic information
Public title
Observational cohort study of acute heart failure in Yokohama, Yokohama Acute Heart Failure (YAHF) registry
Acronym
Yokohama Acute Heart Failure registry
Scientific Title
Observational cohort study of acute heart failure in Yokohama, Yokohama Acute Heart Failure (YAHF) registry
Scientific Title:Acronym
Yokohama Acute Heart Failure registry
Region
| Japan |
Condition
Condition
Acute heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the background, pathophysiology, epidemiology, therapy, and prognosis of acute heart failure.
Basic objectives2
Others
Basic objectives -Others
To clarify the background, pathophysiology(especially to verify the hypothesis that acute change in hemoglobin correlates heart failure profile: e.g. acute pulmonary edema, and that hypercapnia at admission is associated with the mode of admission and acute airway management), epidemiology, therapy, and prognosis of acute heart failure.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pathological, therapeutical, and prognostic parameters. (detailed outcome for above-mentioned hypothesis: acute changes in hemoglobin levels in each subgroups of heart failure (e.g. patients with or without acute pulmonary edema ), and mode of airway management in each subgroups of those with or without hypercapnia).
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
Patients who met Framingham criteria.
Key exclusion criteria
None
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Konishi |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama
TEL
045-261-5656
m_koni@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Konishi |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama
TEL
045-253-5362
Homepage URL
m_koni@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/78/4/78_CJ-13-1163/_pdf
Number of participants that the trial has enrolled
Results
Published in
https://www.jstage.jst.go.jp/article/circj/78/4/78_CJ-13-1163/_pdf
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
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Patients enrollment ended by Dec. 2011. Only data at admission and during hospitalization are now analyzed.
Management information
Registered date
| 2013 | Year | 03 | Month | 04 | Day |
Last modified on
| 2014 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011899
