UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036459
Receipt number R000041500
Scientific Title Japan Pulmonary Hypertension Registry
Date of disclosure of the study information 2019/04/10
Last modified on 2019/04/08 11:31:16

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Basic information

Public title

Japan Pulmonary Hypertension Registry

Acronym

JAPHR

Scientific Title

Japan Pulmonary Hypertension Registry

Scientific Title:Acronym

JAPHR

Region

Japan


Condition

Condition

Pulmonary Hypertension

Classification by specialty

Cardiology Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

comparison of clinical feature

Basic objectives2

Others

Basic objectives -Others

comparison of treatment

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

onset of events
comparison of treatments
frequency of side effects

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Pulmonary Hypertension(2013Nice)

Key exclusion criteria

Patients who are judged by physicians/investigators to be inappropriate to participate in the study

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Yuichi
Middle name
Last name Tamura

Organization

International University of Health and Welfare

Division name

Cardiovascular internal medicine

Zip code

108-8329

Address

1-4-3 Mita, Minato-ku Tokyo

TEL

03-3451-8121

Email

u1@iuhw.ac.jp


Public contact

Name of contact person

1st name Yuichi
Middle name
Last name Tamura

Organization

International University of Health and Welfare, Mita Hospital

Division name

PH center

Zip code

108-8329

Address

1-4-3 Mita, Minato-ku Tokyo

TEL

03-3451-8121

Homepage URL


Email

u1@iuhw.ac.jp


Sponsor or person

Institute

International University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University

Address

53 kawahara-cho, Shogoin, Sakyo-ku, Kyoto

Tel

075-751-3111

Email

ethcom@kuhp.kyoto-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



Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 10 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Enrolling by invitation

Date of protocol fixation

2019 Year 03 Month 20 Day

Date of IRB

2019 Year 04 Month 02 Day

Anticipated trial start date

2019 Year 04 Month 02 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A multicenter prospective observational study


Management information

Registered date

2019 Year 04 Month 10 Day

Last modified on

2019 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041500


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name