UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010601 |
|---|---|
| Receipt number | R000012383 |
| Scientific Title | JApanese heart failure Syndrome with Preserved Ejection fRaction (JASPER)Study |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2020/10/31 09:02:42 |
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Basic information
Public title
JApanese heart failure Syndrome with Preserved Ejection fRaction (JASPER)Study
Acronym
Japanese multicenter registry in heart failure patients with preserved ejection fraction
Scientific Title
JApanese heart failure Syndrome with Preserved Ejection fRaction (JASPER)Study
Scientific Title:Acronym
Japanese multicenter registry in heart failure patients with preserved ejection fraction
Region
| Japan |
Condition
Condition
Acute decompensated heart failure with preserved ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship among characteristics, therapies, and prognosis, in patients with HFpEF.
Basic objectives2
Others
Basic objectives -Others
To link future prospective interventional study.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiovascular death, Admission due to 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
1) Diagnosed as acute deconpensated heart failure based on Framingham criteria
2) Above 20 years old
3) Left ventricular fractional shortning above 25 %, or left ventricular ejection fraction above 50% (modified-Simpson method) measured by echocardiogram.
Key exclusion criteria
1) Acute coronary syndrome, severe valvular disease, transplanted heart, hemodialysis.
2) The patients judged as incompetent in this research by the principal investigator.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihisa Anzai |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
Address
5-7-1 fujishirodai, Suita, Osaka
TEL
06-6833-5012
jasper@ml.ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihisa Anzai |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
Address
5-7-1 fujishirodai, Suita, Osaka
TEL
06-6833-5012
Homepage URL
https://jasper-study.jp/Account/Login.aspx
jasper@ml.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center, Division of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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 | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://jasper-study.jp/Account/Outline.aspx
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2012 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2013 | Year | 04 | Month | 26 | Day |
Last modified on
| 2020 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012383
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
