UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021831
Receipt No. 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 2017/01/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last name of lead principal investigator
1st name
Middle name
Last name Yasushi Sakata
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3631
Email yasushisk@cardiology.med.osaka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shungo Hikoso
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3631
Homepage URL
Email hikoso@cardiology.med.osaka-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 28 Day
Last follow-up date
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
2017 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024414

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.