UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052692 |
|---|---|
| Receipt number | R000056481 |
| Scientific Title | RAre Disease DAta Registry of Japan[78] |
| Date of disclosure of the study information | 2023/11/03 |
| Last modified on | 2023/11/03 14:54:04 |
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Basic information
Public title
Integrated Clinical and Omics information Registry in Pulmonary Hypertension
Acronym
ICOR-PH
Scientific Title
RAre Disease DAta Registry of Japan[78]
Scientific Title:Acronym
RADDAR-J [78]
Region
| Japan |
Condition
Condition
Pulmonary arterial hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the natural history and prognostic factors of pulmonary hypertension and explore the significance of biomarkers including genetic predisposition by accumulating clinical and genetic information on patients with pulmonary hypertension and examining the clinical parameters over long-term period.
Basic objectives2
Others
Basic objectives -Others
In the future, the results will contribute to the development and establishment of new treatment methods for pulmonary hypertension.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Deaths (all cause or disease related))
2) EQ-5D-5L Survey
3) Treatment details
4) Clinical severity including hemodynamics
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed as pulmonary hypertension according to pulmonary hypertension treatment guidelines in one of the following groups: group 1 (pulmonary arterial hypertension), group 1.5 (pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis), group 4 (chronic thromboembolic pulmonary hypertension) or group 5 (pulmonary hypertension associated with a multifactorial mechanism of unknown detail)
2)Patients who consented to participate in the study in writing.
Key exclusion criteria
Patients judged to be inappropriate as a candidate by the investigators.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Matsubara |
Organization
National Hospital Organization Okayama Medical Center
Division name
Cardiology
Zip code
710-1192
Address
1711-1 Tamasu, Kita-ku, Okayama city, Okayama, 701-1192, Japan
TEL
086-294-9911
matsubara.hiromi@gmail.com
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Yanagihara |
Organization
National Hospital Organization Okayama Medical Center
Division name
Clinical Research Department
Zip code
701-1192
Address
1711-1 Tamasu, Kita-ku, Okayama city, Okayama, 701-1192, Japan
TEL
086-294-9911
Homepage URL
ph.registry.raddar.j78@gmail.com
Sponsor or person
Institute
National Hospital Organization Okayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
---
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshidakonoecho, Kyoto Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2023 | Year | 11 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
---
Management information
Registered date
| 2023 | Year | 11 | Month | 03 | Day |
Last modified on
| 2023 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056481
