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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017725
Receipt No. R000020475
Scientific Title Effects of beta-blockers and renin-angiotensin system inhibitors on the prognosis of patients with heart failure with preserved ejection fraction -A multicenter registry
Date of disclosure of the study information 2015/05/29
Last modified on 2019/11/30

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Basic information
Public title Effects of beta-blockers and renin-angiotensin system inhibitors on the prognosis of patients with heart failure with preserved ejection fraction -A multicenter registry
Acronym EASY HFpEF registry
Scientific Title Effects of beta-blockers and renin-angiotensin system inhibitors on the prognosis of patients with heart failure with preserved ejection fraction -A multicenter registry
Scientific Title:Acronym EASY HFpEF registry
Region
Japan

Condition
Condition Heart failure with preservrd left ventricular ejection fraction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the effects of beta-blockers and/or renin-angiotensin system inhibitors on outcomes of patients with heart failure with left ventricular ejection fraction of 40~60% in comparison with those effects on the same outcomes in patients with left ventricular ejection fraction >60%.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes all cause mortality or admission due to heart failure during 2 years after entry to the registry
Key secondary outcomes all cause mortality addmission due to cardivascular disease
death due to cardiovascular diease
addmission due to heart failure
strengthen the heart failure therapy

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 Patients who admitted to the hospitals due to acute decompensated heart failure and their left ventricular ejection fraction >40%.
Key exclusion criteria Patients with significant valvular heart disease, those with devices such as permanent pacemaker, CRT-P,and CRT-D, those with significant arrhythmias, and those with resercher think that they are not eligible.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Ohte
Organization Nagoya City University Graduate School of Medical Sciences
Division name Cardiology
Zip code 467-8601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL 052-853-8221
Email ohte@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Nobuyuki
Middle name
Last name Ohte
Organization Nagoya City University Graduate School of Medical Sciences
Division name Cardiology
Zip code 467-8601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL 052-853-8221
Homepage URL
Email ohte@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya Rinsho Yakuri Kenkyusho
Institute
Department

Funding Source
Organization Nagoya City University
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 Nagoya City University Hospital Clinical Research Management Center
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel 052-851-5511
Email ctmc@med.nagoya-cu.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
2015 Year 05 Month 29 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 Open public recruiting
Date of protocol fixation
2014 Year 08 Month 28 Day
Date of IRB
2015 Year 10 Month 24 Day
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 05 Month 31 Day
Date trial data considered complete
2021 Year 07 Month 01 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information Drug therapy for the patients with heart failure with preserved left ventricular (LV) ejection fraction (HFpEF) has not been established. Accordingly, we attempt to observe the effects of beta-blockers and/or renin-angiotensin system inhibitors, with which the beneficial effects on the all-cause mortality and re-admission due to heart failure has been confirmed, on the patients with HFpEF. Based on our previous findings, the threshold value to distinguish LVs with good systolic function and deteriorated systolic function was 58%. We consider that patients with LVEF of 40~60% has LV systolic dysfunction to some extent. Thus, we will compared the effects of beta-blockers and/or renin-angiotensin system inhibitors between the HF patients with LVEF of 40~60% and those with LVEF>60%. Our hypothesis is that beta-blockers and/or renin-angiotensin system inhibitors should have significant effects on the prognosis in patients with LVEF of 40~60%.

Management information
Registered date
2015 Year 05 Month 28 Day
Last modified on
2019 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020475

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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