臨床研究等提出・公開システム

Japanese

Date of registration	July. 08, 2023
Last modified on	July. 08, 2023
Trial ID	jRCT1010230018

Scientific Title	A PrOsPectve cohort study on interstitial Lung disease-Associated pulmonary hypertension with a particulaR focus on the subset with pulmonary arterial hypertension-feature (POPLAR study)
Public Title	POPLAR study (POPLAR study)

Contact for Scientific Queries	Name	Tsujino Ichizo
	Affiliation	Hokkaido University
	Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido
	Telephone	+81-11-706-5911
	E-mail	itsujino@med.hokudai.ac.jp
Contact for Public Queries	Name	Tsujino Ichizo
	Affiliation	Hokkaido University
	Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido
	Telephone	+81-11-706-5911
	E-mail	itsujino@med.hokudai.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Sept. 01, 2023
Actual date of first enrollment
Target sample size		250
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Male or female who are >=20 years of age at the time of initial PH or ILD diagnosis. 2. With a diagnosis of PAH, ILD-PH, or ILD-no PH at the time of study entry 3.Individuals who voluntarily consent to participate in the study with sufficient understanding after receiving a detailed explanation of it
	Exclusion Criteria	1. Patients who are diagnosed with PH, but classified as group 2, 4, or 5 2. Patients who are classified as group 3 PH without PAH, but have received medication for PAH before baseline 3. Patients who are diagnosed with ILD, the state of which is however expected to change rapidly, including respiratory infection, and drug-induced pneumonia 4. [Prevalent patient only] patients whose first ILD or PH diagnosis was before January 1, 2010. 5. Other individuals who, in the opinion of the sponsor, are not appropriate patients
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pulmonary hypertension, Interstitial lung disease
Intervention(s)
Health Condition(s) Keyword		Pulmonary hypertension, Interstitial lung disease
Intervention(s) Keyword
Health Condition(s) Code		D006976, D017563
Intervention(s) Code
Primary Outcome(s)		Pulmonary vascular resistance
Secondary Outcome(s)		Data of right heart catheterization, cardiac MRI, respiratory function test, echocardiography, chest CT, urine/blood test, genetic test, biomarker, questionnaire

Primary Sponsor	Janssen Pharmaceutical K.K

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hokkaido University Hospital Clinical Research Administration Center
Address	North 15, West 5, Kita-ku, Sapporo, Hokkaido, Hokkaido
Telephone	+81-11-706-7636
E-Mail	crjimu@huhp.hokudai.ac.jp
Approval Status	Approval
Date of approval	June. 14, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none