UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter prospective survey of pulmonary hypertension
Acronym	A multicenter prospective survey of pulmonary hypertension
Scientific Title	A multicenter prospective survey of pulmonary hypertension
Scientific Title:Acronym	A multicenter prospective survey of pulmonary hypertension
Region	Japan

Condition
Condition	pulmonary hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We investigate the current situation of diagnosis and treatment for pulmonary hypertension (PH) prospectively in Japan, and construct the database. And our aim is to establish the diagnostics and treatment for PH by elucidating the pathophysiology and mechanism of the disease.
Basic objectives2	Others
Basic objectives -Others	We investigate the current situation of diagnosis and treatment for pulmonary hypertension (PH) prospectively in Japan, and construct the database. And our aim is to establish the diagnostics and treatment for PH by elucidating the pathophysiology and mechanism of the disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cardiovascular events (hospitalization for congestive heart failure or worsening primary disease, and developing life-threatening cardiovascular disease) and prognosis (cardiovascular and non-cardiovascular death, all-cause death)
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	1) Patients who enrolled in the multicenter retrospective survey of pulmonary hypertension 2) Patients who newly performed right heart catheterization and diagnosed as pulmonary hypertension
Key exclusion criteria	Patients who were considered as inappropriate candidates for the survey by phsicians
Target sample size	1000

Research contact person
Last name of lead principal investigator	1st name Hiroaki Middle name Last name Shimokawa
Organization	Tohoku University Graduate School of Medicine
Division name	Cardiovascular Medicine
Zip code	980-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7153
Email	shimo@cardio.med.tohoku.ac.jp

Public contact
1st name of contact person	1st name Koichiro Middle name Last name Sugimura
Organization	Tohoku University Graduate School of Medicine
Division name	Cardiovascular Medicine
Zip code	980-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7153
Homepage URL
Email	ksugimura@cardio.med.tohoku.ac.jp

Sponsor
Institute	Japanese Pulmonary Circulation Study Group
Institute
Department

Funding Source
Organization	Japanese Pulmonary Circulation Study Group
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	Tohoku University Graduate School of Medicine
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	2016 Year 05 Month 27 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	No longer recruiting
Date of protocol fixation	2014 Year 06 Month 03 Day
Date of IRB	2014 Year 06 Month 03 Day
Anticipated trial start date	2014 Year 06 Month 03 Day
Last follow-up date	2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	cohort study

Management information
Registered date	2016 Year 05 Month 25 Day
Last modified on	2019 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025715