UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011541
Receipt number R000013498
Scientific Title Multi-institutional Prospective Registry in Pulmonary Hypertension associated with Respiratory Disease
Date of disclosure of the study information 2013/09/01
Last modified on 2022/03/01 08:40:29

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Basic information

Public title

Multi-institutional Prospective Registry
in Pulmonary Hypertension associated
with Respiratory Disease

Acronym

Japan Respiratory PH study

Scientific Title

Multi-institutional Prospective Registry
in Pulmonary Hypertension associated
with Respiratory Disease

Scientific Title:Acronym

Japan Respiratory PH study

Region

Japan


Condition

Condition

Pulmonary Hypertension Associated
with Respiratory Disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

First prospective registry in pulmonary hypertension (PH) associated with respiratory disease including borderline PH confirmed by right heart catheterization in Japan. Prevalence of pulmonary arterial hypertension (PAH) specific therapy for PH associated with respiratory disease, course, survival and prognostic factors, efficacy and safety of PAH specific drugs are investigated.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Lung transplantation
Worsening of NHYA,
Addition of PAH specific drugs,
Hospitalization due to PH
Prevalence of progression from borderline PH

Key secondary outcomes

Liver dysfunction
Edema
Adverse effects of drugs
Pregnancy
Hospitalization due to infection and respiratory failure
Mechanical ventilation


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

Patients >=18 years old with PH including borderline PH (mean pulmonary arterial pressure 20-25mmHg) associated with respiratory disease by right heart catheterization

Key exclusion criteria

Patients who refused this study
Under 18 years old

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Nobuhiro
Middle name
Last name Tanabe

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Advanced Medicine in Pulmonary Hypertension

Zip code

260-8670

Address

1-8-1 Inohana, Chuou-ku, Chiba 263-0043

TEL

043-222-7171

Email

ntanabe@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Nobuhiro
Middle name
Last name Tanabe

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Respirology

Zip code

260-8670

Address

1-8-1 Inohana, Chuou-ku, Chiba 263-0043

TEL

043-222-7171

Homepage URL


Email

ntanabe@faculty.chiba-u.jp


Sponsor or person

Institute

Steering Committee for Multi-institutional Prospective Registry in Pulmonary Hypertension associated
with Respiratory Disease

Institute

Department

Personal name



Funding Source

Organization

NPO Japan PH Registry

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Department of Healthcare Quality Assessment, Graduate School of Medicine, University of Tokyo, The University of Tokyo

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate School of Medicine, Chiba University

Address

1-8-1 Inohana, Chuou-ku, Chiba

Tel

043-222-7171

Email

igaku-rinri@office.chiba-u.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

北海道大学病院第一内科(北海道)、JA北海道厚生連帯広厚生病院(北海道)、千葉大学大学院医学研究院呼吸器内科学(千葉県)、東邦大学医療センター佐倉病院(千葉県)、東京大学循環器内科(東京都)、順天堂大学呼吸器内科(東京都)、JR東京総合病院呼吸器内科 (東京都)、東海大学八王子医療センタ(東京都)、JCHO東京新宿病院(東京都)、慶應義塾大学医学部(東京都)、杏林大学循環器内科(東京都)、国立病院機構東京病院(東京都)、国際医療福祉大学三田病院(東京都)、神奈川県立呼吸器循環器病センター(神奈川)、東海大学医学部付属病院(神奈川県)、信州大学第一内科(長野県)、長野赤十字病院(長野県)、金沢市立病院(石川県)、公立陶生病院呼吸器・アレルギー内科(愛知県)、京都大学大学院医学研究科呼吸器内科学(京都府)、奈良県立医科大学第ニ内科(奈良県)、国立循環器病研究センター(大阪府)、国立病院機構近畿中央胸部疾患センター(大阪府)、大阪市立総合医療センター(大阪府)近畿大学医学部呼吸器・アレルギー内科(大阪府)、神戸大学医学部付属病院(兵庫県)、国立病院機構岡山医療センター(岡山県)、福岡大学医学部呼吸器内科(福岡県)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 01 Day


Related information

URL releasing protocol

https://www.jstage.jst.go.jp/article/circj/85/4/85_CJ-20-0939/_article

Publication of results

Partially published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/circj/85/4/85_CJ-20-0939/_article

Number of participants that the trial has enrolled

281

Results

281 patients with R-PH were included in this study. 43% had mild ventilatory impairment (MVI), 52% had a severe form of PH. 68% received PAH-targeted therapies. In MVI, those treated initially had better survival than patients not treated initially (3-year survival 70.6% vs. 34.2%; P=0.01), and no significant difference was obsereved in severe ventilatory impairment (49.6% vs. 32.1%; P=0.38). Responders to PAH-targeted therapy were more prevalent in the group with MVI.

Results date posted

2021 Year 08 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 02 Month 02 Day

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

2013 Year 05 Month 31 Day

Date of IRB

2013 Year 05 Month 31 Day

Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective descriptions of new and additional treatment for respiratory PH.
Analysis of effects of PAH specific drugs in following subcategories
Subcategorical analysis
Severity of PH (mean PA 25 to 35mmHg and >=35mmHg)
Pulmonary arterial wedge pressure (=<15mmHg and >15mmHg)
Diseases
Effects of PAH specific drugs for exercise tolerance, hemodynamic parameters by right heart catheterization, and gas exchange.
Especially efficacy and safety of PDE-5 inhibitors for respiratory PH.
Clarify the characteristics of Responder for PAH therapy


Management information

Registered date

2013 Year 08 Month 21 Day

Last modified on

2022 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013498


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name