UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022449 |
|---|---|
| Receipt number | R000025715 |
| Scientific Title | A multicenter prospective survey of pulmonary hypertension |
| Date of disclosure of the study information | 2016/05/27 |
| Last modified on | 2019/05/29 15:57:50 |
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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
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
shimo@cardio.med.tohoku.ac.jp
Public contact
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
ksugimura@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Japanese Pulmonary Circulation Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025715
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
