UMIN-CTR Clinical Trial

Basic information
Public title	Comprehensive analysis of biomarkers in patients with pulmonary arterial hypertension
Acronym	Comprehensive analysis of biomarkers in patients with pulmonary arterial hypertension
Scientific Title	Comprehensive analysis of biomarkers in patients with pulmonary arterial hypertension
Scientific Title:Acronym	Comprehensive analysis of biomarkers in patients with pulmonary arterial hypertension
Region	Japan

Condition
Condition	Pulmonary arterial hypertension
Classification by specialty	Cardiology Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identification of Immune-responsive phenotyp
Basic objectives2	Others
Basic objectives -Others	Immune-responsive phenotype threshold
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification of Immune-responsive phenotyp
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with pulmonary arterial pulmonary hypertension registered or scheduled to be registered in JAPHR
Key exclusion criteria	Patients who have received biologics within 3 months before blood collection for this study Patients who withdrew consent to participate in JAPHR Patients who refused to participate in this study Judged by the investigator
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yuichi Middle name Last name Tamura
Organization	International University of Health and Welfare, Mita Hospital
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	Cardiovascular internal medicine
Zip code	108-8329
Address	1-4-3 Mita, Minato-ku Tokyo
TEL	03-3451-8121
Homepage URL
Email	u1@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	International University of Health and Welfare
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Chiba University Nippon Medical School Kyusyu University Kyorin University Kobe University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	International University of Health and Welfare, Mita Hospital
Address	1-4-3 Mita, Minato-ku Tokyo, 108-832
Tel	03-3451-8121
Email	soumu-mita.hosp@iuhw.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	2020 Year 03 Month 16 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	Completed
Date of protocol fixation	2020 Year 02 Month 29 Day
Date of IRB	2020 Year 02 Month 29 Day
Anticipated trial start date	2020 Year 02 Month 29 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

Observation Year of birth, sex, height, weight, presence or absence of pregnancy, date of diagnosis of pulmonary hypertension, NYHA classification, etiology, 6MWT, PRO index, hemodynamic measurements, respiratory function test, electrocardiogram rhythm, blood test, thyroid function Abnormalities, PH / PAH specific treatments, anticancer drugs, clinical events, clinical events Biomarker Blood collection 5ml

Management information
Registered date	2020 Year 03 Month 16 Day
Last modified on	2022 Year 01 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045419