UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000035217
Receipt No. 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 (Ver. 8)

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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
Email 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
Email s-satoru@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039593