UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052673 |
|---|---|
| Receipt number | R000060113 |
| Scientific Title | Study of sex difference in pathogenesis of heart failure and development of preventive strategy |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/11/01 18:20:15 |
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Basic information
Public title
Study of sex difference in pathogenesis of heart failure and development of preventive strategy
Acronym
Study of sex difference in heart failure
Scientific Title
Study of sex difference in pathogenesis of heart failure and development of preventive strategy
Scientific Title:Acronym
Study of sex difference in heart failure
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
HFpEF(Heart Failure with Preserved Ejection Fraction) is more prevalent in women and the risk of HFpEF increases more drastically with age in women than men. Our research focus on sex difference of heart failure pathogenesis and development of preventive strategy.
Basic objectives2
Others
Basic objectives -Others
pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sex hormones and circulating micro-RNAs of heart failure patients
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
| 60 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized for heart failure. Patients who have no medical history of heart failure and have one more cardiovascular risks(Hypertension, Diabetes Mellitus, Obesity, Atrial Fibrillation).
Key exclusion criteria
Patients who have received hormone replacement therapy within one year.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Eiki |
| Middle name | |
| Last name | Takimoto |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo.
TEL
03-3815-5411
eikitakimoto@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Toyoda |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo.
TEL
03-3815-5411
Homepage URL
mtoyoda-tky@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo.
Tel
03-3815-5411
ethics@m.u-tokyo.ac.jp
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
東京大学医学部附属病院（東京都）、杏林大学医学部付属病院（東京都）、自治医科大学附属さいたま医療センター（埼玉県）、慶應義塾大学病院（東京都）、順天堂大学医学部附属順天堂医院（東京都）、堀切中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we collect blood and urine samples from study participants and analyze sex hormones and circulating micro-RNAs.
Management information
Registered date
| 2023 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060113
