UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033784 |
|---|---|
| Receipt number | R000038539 |
| Scientific Title | Multicenter registry of chronic thromboembolic pulmonary hypertension in Japan |
| Date of disclosure of the study information | 2018/08/20 |
| Last modified on | 2025/02/18 20:41:03 |
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Basic information
Public title
Multicenter registry of chronic thromboembolic pulmonary hypertension in Japan
Acronym
CTEPH Anticoagulant Registry
Scientific Title
Multicenter registry of chronic thromboembolic pulmonary hypertension in Japan
Scientific Title:Acronym
CTEPH Anticoagulant Registry
Region
| Japan |
Condition
Condition
Chronic thromboembolic pulmonary hypertension
Classification by specialty
| Cardiology | Pneumology | Vascular surgery |
| Chest surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of the treatment in chronic thromboembolic pulmonary hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
First occurrence of morbidity and mortality events, a composite endpoint composed of the following
1. All-cause death, and/or
2. Lung transplantation, and/or
3. CTEPH worsening-related rescue pulmonary endarterectomy, rescue balloon pulmonary angioplasty, or the start of parenteral pulmonary vasodilator, and/or
4. >= 15% reduction in 6-minute walk distance accompanied by worsening of WHO functional class
First occurrence of clinically relavant bleeding, a composite endpoint composed of major bleeding and clinically relevant non-major bleeding based on ISTH 2015
Key secondary outcomes
First occurrence of symptomatic venous thromboembolism
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
1. Patients must had been or be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) (i.e. prevalent and incident patients)
2. Patients must meet the following criteria for CTEPH at diagnosis:
Mean pulmonary artery pressure (PAP) >= 25 mmHg and mean pulmonary artery wedged pressure <= 15 mmHg at rest.
Abnormal VQ scan, pulmonary angiogram, or computed tomography (CT) pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines.
The above criteria should be judged after at least 3 months of effective anticoagulation therapy.
3. Patients must be willing to provide informed consent.
Key exclusion criteria
Principle investigator or co-investigator judged the patient inappropriate.
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Abe |
Organization
Kyushu University Hospital
Division name
Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5360
hosokawa.kazuya.712@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Hosokawa |
Organization
Kyushu University Hospital
Division name
Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5360
Homepage URL
hosokawa.kazuya.712@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5360
hosokawa.kazuya.712@m.kyushu-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
1. Division of Cardiovascular Medicine, Kobe University Hospital, Kobe, Japan.
2. Department of Cardiovascular Medicine, Kyorin University School of Medicine, Tokyo, Japan.
3. Department of Cardiology, Nagoya University Hospital, Nagoya, Japan
4. Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka, Japan
5. Department of Respiratory Medicine, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
6. Department of Cardiovascular Surgery1, Cardiology2, Tokyo Medical University, Tokyo, Japan
7. Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
8. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
9. Department of Cardiology1, Clinical Science2, National Hospital Organization Okayama Medical Centre, Okayama, Japan.
10. Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan
11. Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
12. Department of Cardiovascular Medicine, Kure Kyosai Hospital, Kure, Japan.
13. Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Japan.
14. Department of Cardiology, Matsuyama Red Cross Hospital, Matsuyama, Japan.
15. Pulmonary Hypertension Center, Chibaken Saiseikai Narashino Hospital, Narashino, Japan
16. Department of Cardiovascular Medicine, Nephrology and Neurology, Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan.
17. Department of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.
18. Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
19. Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan.
20. Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
21. Pulmonary Hypertension Center, International University of Health and Welfare Mita Hosipital, Tokyo, Japan
22. Division of Cardiology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
23. Department of Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan.
24. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto university graduate school of medical sciences, Kumamoto, Japan.
25. Department of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.
26. Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan
27. Department of Cardiology, Tokyo Women' Medical University, Tokyo, Japan.
28. Department of Cardiology, International University of Health and Welfare Narita Hospital, Narita, Japan.
29. Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University, Sapporo, Japan.
30. Division of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 20 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 24 | Day |
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038539
