UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035217 |
|---|---|
| Receipt number | R000039593 |
| Scientific Title | H2FPEF Score for Identifying the High Risk Patients for Heart Failure-Related Events in Stable Outpatients with Cardiovascular Risk Factors |
| Date of disclosure of the study information | 2018/12/17 |
| Last modified on | 2019/11/06 10:38:39 |
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Basic information
Public title
H2FPEF Score for Identifying the High Risk Patients for Heart Failure-Related Events in Stable Outpatients with Cardiovascular Risk Factors
Acronym
The association between H2FPEF Score and outpatients
Scientific Title
H2FPEF Score for Identifying the High Risk Patients for Heart Failure-Related Events in Stable Outpatients with Cardiovascular Risk Factors
Scientific Title:Acronym
The association between H2FPEF Score and outpatients
Region
| Japan |
Condition
Condition
Heart Failure related events
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether the H2FPEF score could identify the high risk patients for heart failure (HF) in stable outpatients with cardiovascular risk factor(s).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HF-related event as a composite of cardiovascular death and hospitalization for HF decompensation
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
stable outpatients with cardiovascular risk factor(s)
Key exclusion criteria
Left ventricular ejection fraction less than 50%
Severe valvular diseas
End stage of chronic kidney diseas including hemodialysis
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City 860-8556, Japan
TEL
0963735175
tsujita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | SUZUKI |
Organization
Graduate School of Medical Science,Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City 860-8556, Japan
TEL
0963735175
Homepage URL
s-satoru@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
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
Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City 860-8556, Japan
Tel
0963735175
s-satoru@kumamoto-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
356
Results
The H2FPEF score could provide useful information for future HF-related events in stable outpatients with cardiovascular risk factor(s) in Japan.
Results date posted
| 2019 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Stable Japanese outpatients with at least 1 cardiovascular risk factor who were enrolled between September 2010 and July 2013, the 356 outpatients (171 men, 185 women, mean age 73.2 years) were eligible for the analysis.
Participant flow
Stable Japanese outpatients with at least 1 cardiovascular risk factor who were enrolled between September 2010 and July 2013, the 356 outpatients (171 men, 185 women, mean age 73.2 years) were eligible for the analysis.
Adverse events
Nothing.
Outcome measures
Heart Failure Event.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients have been followed-up regularly for the occurrence of cardiovascular event.
Management information
Registered date
| 2018 | Year | 12 | Month | 11 | Day |
Last modified on
| 2019 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039593
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
