UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039741 |
|---|---|
| Receipt number | R000045326 |
| Scientific Title | A prospective observational cohort study to identify novel therapeutic efficacy indicators for patients with pulmonary hypertension |
| Date of disclosure of the study information | 2020/03/09 |
| Last modified on | 2020/03/09 10:07:29 |
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Basic information
Public title
A prospective observational cohort study to identify novel therapeutic efficacy indicators for patients with pulmonary hypertension
Acronym
A prospective observational cohort study to identify novel therapeutic efficacy indicators for patients with pulmonary hypertension
Scientific Title
A prospective observational cohort study to identify novel therapeutic efficacy indicators for patients with pulmonary hypertension
Scientific Title:Acronym
A prospective observational cohort study to identify novel therapeutic efficacy indicators for patients with pulmonary hypertension
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to apply new indices based on new biomarkers to the treatment of pulmonary hypertension
Basic objectives2
Others
Basic objectives -Others
Establish new indicators with new biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to apply new indices based on new biomarkers to the treatment of pulmonary hypertension
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
-
Key exclusion criteria
none
Target sample size
100
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
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
PH center
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku Tokyo
TEL
03-3451-8121
Homepage URL
u1@iuhw.ac.jp
Sponsor or person
Institute
Ministry of Health, Labor and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
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 | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2020 | Year | 03 | Month | 09 | Day |
Last modified on
| 2020 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045326
