UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034669
Receipt number R000039524
Scientific Title 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 2020/04/28 14:59:49

* 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

The Adequacy of New Definition of Pulmonary Hypertension in Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction

Acronym

Pulmonary Hypertension in HFpEF

Scientific Title

The Adequacy of New Definition of Pulmonary Hypertension in Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction

Scientific Title:Acronym

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

1st name Kenichi
Middle name
Last name Tsujita

Organization

Graduate School of Medical Sciences, Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code

860-8556

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

1st name Taiki
Middle name
Last name Nishihara

Organization

Graduate School of Medical Sciences, Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code

860-8556

Address

1-1-1 Honjo, Chuo-ku, Kumamoto, Japan

TEL

81-96-373-5175

Homepage URL


Email

t-nishi@kumamoto-u.ac.jp


Sponsor or person

Institute

Kumamoto University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Graduate School of Medical Sciences, Kumamoto University

Address

1-1-1 Honjo, Chuo-ku, Kumamoto, Japan

Tel

81-96-373-5657

Email

ski-shien@jimu.kumamoto-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

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


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.atsjournals.org/doi/10.1164/rccm.201901-0148LE

Number of participants that the trial has enrolled

183

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

Main results already published

Date of protocol fixation

2007 Year 01 Month 10 Day

Date of IRB

2017 Year 09 Month 19 Day

Anticipated trial start date

2007 Year 01 Month 20 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

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

2020 Year 04 Month 28 Day



Link to view the page

Value
https://center6.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