UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017725 |
|---|---|
| Receipt number | 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 | 2023/04/11 19:17:29 |
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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
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
ohte@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya Rinsho Yakuri Kenkyusho
Institute
Department
Personal name
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
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
https://academic.oup.com/ehjcimaging/
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/ehjcimaging/
Number of participants that the trial has enrolled
255
Results
Diagnostic performance plot analysis demonstrated that the discrimination threshold value for LVEF that could identify patients prone to reaching the primary endpoint was >=57.2%. A higher LVEF is independently related to poor prognosis in patients with HFpEF, in addition to concurrent AF and elevated E/e' ratio. ACEI/ARB use, in contrast, was associated with improved prognosis, especially in regard to readmission due to HF.
Results date posted
| 2023 | Year | 04 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The EASY HFpEF registry was a multicentre, prospective, observational cohort study that registered patients hospitalized with a diagnosis of acute decompensated HF according to the Framingham criteria and LVEF >40% by the modified Simpson's method based on echocardiography at discharge.
Participant flow
Thirteen university hospitals and three regional core hospitals participated in this study. Patients with an acute coronary syndrome, more than moderate grade heart valve disease, history of cerebrovascular disease, or who were receiving haemodialysis were excluded. The registered patients were followed after discharge for at least 1 year and up to 2 years.
Adverse events
None
Outcome measures
The primary endpoint of this study was a combined outcome of death from any cause and readmission due to HF. The secondary endpoint was readmission due to HF.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | 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
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020475
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