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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034669
Receipt No. R000039524
Official scientific title of the study The Adequacy of New Definition of Pulmonary Hypertension in Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction
Date of disclosure of the study information 2018/11/02
Last modified on 2018/10/27

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Basic information
Official scientific title of the study The Adequacy of New Definition of Pulmonary Hypertension in Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction
Title of the study (Brief title) Pulmonary Hypertension in HFpEF
Region
Japan

Condition
Condition Heart failure with preserved ejection fraction (HFpEF)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the relationship between pulmonary arterial pressure (PAP) levels and other biomarker of HF in patient with HFpEF and to investigate the prognostic involvement of PAP levels in the future cardiovascular events in patients with HFpEF.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite endopoint of cardiovascular death, non-fatal myocardial infarction, unstable anginapectoris, non-fatal stroke, or re-hospitalization for heart failure
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients with HF who were hospitalized in Kumamoto University Hospital
Key exclusion criteria Do not meet diagnostic criteria for HFpEF
Severe valvular disease
Systemic inflammatory disease
End stage of chronic kidney disease
Target sample size 500

Research contact person
Name of lead principal investigator Kenichi Tsujita
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
TEL 81-96-373-5175
Email cvmhisho@kumamoto-u.ac.jp

Public contact
Name of contact person Taiki Nishihara
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
TEL 81-96-373-5175
Homepage URL
Email t-nishi@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)

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 熊本大学病院(熊本県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 02 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2007 Year 01 Month 10 Day
Anticipated trial start date
2007 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Patients were followed at the outpatient clinic until December 2016 or until an endpoint occured.

Management information
Registered date
2018 Year 10 Month 27 Day
Last modified on
2018 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039524

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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