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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033436
Receipt No. 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

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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
Email 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
Email akasaka-cba@umin.ac.jp

Sponsor
Institute Shonan Fujisawa Tokushukai Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033414

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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