UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060978 |
|---|---|
| Receipt number | R000069779 |
| Scientific Title | Impact of LOX on CTEPH |
| Date of disclosure of the study information | 2026/03/19 |
| Last modified on | 2026/03/18 22:44:14 |
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Basic information
Public title
Impact of LOX on CTEPH
Acronym
LOX in CTEPH
Scientific Title
Impact of LOX on CTEPH
Scientific Title:Acronym
LOX in CTEPH
Region
| Japan |
Condition
Condition
Chronic Thromboembolic Pulmonary Hypertension(CTEPH)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Elucidating the clinical significance of somatic mosaicism will lead to a better understanding of novel mechanisms underlying the onset and progression of various age-related diseases. Furthermore, it may provide fundamental insights for the development of new therapeutic strategies. A deeper understanding of the characteristics and progression mechanisms of diseases associated with somatic mosaicism is also expected to contribute to improvements in prevention and treatment strategies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
heart failure hospitalization, residual HOT, and re-intervention
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with CTEPH after treatment
Key exclusion criteria
A patient from whom consent cannot be obtained
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Anzai |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
1608583
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
atsushi_anzai@keio.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Anzai |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
1608582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
atsushi_anzai@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel
03-3353-1211
atsushi_anzai@keio.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
| 2026 | Year | 03 | Month | 19 | 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
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the significance of LOX in CTEPH, we will analyze peripheral blood LOX (%) in patients in relation to outcomes, patient characteristics, and laboratory findings.
Management information
Registered date
| 2026 | Year | 03 | Month | 18 | Day |
Last modified on
| 2026 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069779
