UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033436 |
|---|---|
| Receipt number | R000033414 |
| Scientific Title | The Current State of heart failure with preserved ejection fraction in Japan: From Etiology to Treatment |
| Date of disclosure of the study information | 2018/07/18 |
| Last modified on | 2018/07/18 18:34:42 |
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Basic information
Public title
The Current State of heart failure with preserved ejection fraction in Japan: From Etiology to Treatment
Acronym
The Current State of Heart Failure with Preserved Ejection Fraction in Japan: From Etiology to Treatment
Scientific Title
The Current State of heart failure with preserved ejection fraction in Japan: From Etiology to Treatment
Scientific Title:Acronym
The Current State of Heart Failure with Preserved Ejection Fraction in Japan: From Etiology to Treatment
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prevalence and current treatment of HFpEF in Japan
Basic objectives2
Others
Basic objectives -Others
To elucidate standard values and distributions of Japanese parameters
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Events are described by all-cause death, hospitalization by cardiovascular disease, heart failure, and apoplexy, or receiving endovascular therapy (data from Diagnosis Procedure Combination database)
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
all cases receiving first echocardiogram
Key exclusion criteria
none
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Saito |
Organization
Shonan Kamakura General Hospital
Division name
Cardiology & Catheterization Laboratories
Zip code
Address
Okamoto 1370-1, Kamakura, Kanagawa
TEL
0467-46-1717
akasaka2013@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Akasaka |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Cardiology & Catheterization Laboratories
Zip code
Address
Tsujido-Kandai 1-5-1, Fujisawa, Kanagawa
TEL
0466-35-1177
Homepage URL
akasaka-cba@umin.ac.jp
Sponsor or person
Institute
Shonan Fujisawa Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Fujisawa Tokushukai Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The standard values and distributions of the echocardiogram parameters are calculated in echocardiographic healthy population.
The heart chamber size is decreased over age while LVMI keep on increasing especially in female, suggesting female has more risk of concentric hypertrophy.
The diastolic function is impaired over age.
The diastolic dysfunction in echocardiographic healthy population could increases cardiovascular events.
Management information
Registered date
| 2018 | Year | 07 | Month | 18 | Day |
Last modified on
| 2018 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033414
