UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021831 |
|---|---|
| Receipt number | R000024414 |
| Scientific Title | Prospective, Multicenter, Observational Study for the Prognosis of patients with Heart Failure with Preserved Ejection Fraction |
| Date of disclosure of the study information | 2016/04/07 |
| Last modified on | 2023/10/15 18:11:16 |
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Basic information
Public title
Prospective, Multicenter, Observational Study for the Prognosis of patients with Heart Failure with Preserved Ejection Fraction
Acronym
Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection Fraction (PURSUIT-HFpEF)
Scientific Title
Prospective, Multicenter, Observational Study for the Prognosis of patients with Heart Failure with Preserved Ejection Fraction
Scientific Title:Acronym
Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection Fraction (PURSUIT-HFpEF)
Region
| Japan |
Condition
Condition
Heart failure with preserved ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate patients with heart failure with preserved ejection fraction comprehensively
Basic objectives2
Others
Basic objectives -Others
To investigate patients' background, factors involved in the disease and the prognosis in patients with HFpEF, to clarify the mechanism of the disease and identify the predictors of the prognosis, and to provide new insight leading to development of diagnostics and treatments of HFpEF
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
survival from registration
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized for heart failure (diagnosed by using Framingham criteria) who meet both of the following criteria:
a left ventricular ejection fraction of 50% or more as measured at the local site by means of echocardiography, and
an elevated level of N terminal pro brain natriuretic peptide (NT proBNP) (400 pg per milliliter or more) or brain natriuretic peptide (BNP)(100 pg per milliliter or more)
Key exclusion criteria
Patients with severe valvular heart disease including aortic stenosis, aortic regurgitation, mitral stenosis and mitral regurgitation; acute coronary syndrome; severe systemic illness except for cardiac disease with a life expectancy of less than 6 months; or after heart transplantation
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Sakata |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3631
yasushisk@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shungo |
| Middle name | |
| Last name | Hikoso |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3631
Homepage URL
hikoso@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
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
Osaka university hospital
Address
2-15 Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8289
rinri@hp-crc.med.osaka-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
大阪大学医学部附属病院（大阪府）、市立池田病院（大阪府）、NTT西日本大阪病院（大阪府）、国立病院機構大阪医療センター（大阪府）、大阪警察病院（大阪府）、大阪府立急性期・総合医療センター（大阪府）、大阪成人病センター（大阪府）、国立病院機構大阪南医療センター（大阪府）、大阪労災病院（大阪府）、加納総合病院（大阪府）、川崎病院（大阪府）、河内総合病院（大阪府）、市立川西病院（大阪府）、関西労災病院（兵庫県）、紀南病院（和歌山県）、公立学校共済組合 近畿中央病院（兵庫県）、兵庫県立西宮病院（兵庫県）、神戸掖済会病院（兵庫県）、大阪府済生会千里病院（大阪府）、桜橋渡辺病院（大阪府）、地域医療機能推進機構JCHO大阪病院（大阪府）、地域医療機能推進機構JCHO大阪みなと病院（大阪府）、地域医療機能推進機構JCHO星ヶ丘医療センター（大阪府）、市立吹田市民病院（大阪府）、住友病院（大阪府）、市立豊中病院（大阪府）、東大阪市立総合病院（大阪府）、箕面市立病院（大阪府）、八尾市立病院（大阪府）、りんくう総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 28 | 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
This study is an observational study using the prospectively maintained database. The subjects consist of all the patients who meet inclusion criteria and do not conflict with exclusion criteria. Patients' data are collected during hospitalization and every one year after discharge and patients are followed up to 5 years after discharge.
Management information
Registered date
| 2016 | Year | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024414
| Research Plan | |
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| 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 |
