UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056178 |
|---|---|
| Receipt number | R000064150 |
| Scientific Title | An observational study evaluating the efficacy and safety of balloon pulmonary angioplasty and selexipag combination therapy in chronic thromboembolic pulmonary hypertension |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/11/18 10:02:50 |
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Basic information
Public title
An observational study evaluating the efficacy and safety of balloon pulmonary angioplasty and selexipag combination therapy in chronic thromboembolic pulmonary hypertension
Acronym
An observational study evaluating the efficacy and safety of balloon pulmonary angioplasty and selexipag combination therapy in chronic thromboembolic pulmonary hypertension
Scientific Title
An observational study evaluating the efficacy and safety of balloon pulmonary angioplasty and selexipag combination therapy in chronic thromboembolic pulmonary hypertension
Scientific Title:Acronym
An observational study evaluating the efficacy and safety of balloon pulmonary angioplasty and selexipag combination therapy in chronic thromboembolic pulmonary hypertension
Region
| Japan |
Condition
Condition
Chronic thromboembolic pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic thromboembolic pulmonary hypertension (CTEPH) is a chronic obstruction of the pulmonary arteries caused by an organic thrombus, which is complicated by pulmonary hypertension and dyspnea on exertion. In Japan, balloon pulmonary angioplasty (BPA) and pulmonary vasodilators are widely used in many patients with CTEPH, and the only pulmonary vasodilators indicated for CTEPH are riociguat (Adempas) and selexipag (Uptravi). As selexipag is a relatively new indication for CTEPH, there is little information on its usefulness in combination therapy with BPA. On the other hand, selexipag is thought to have the advantage of fine-tuning the dose, allowing treatment to be tailored to the medical condition and comorbidities of patients with CTEPH. The objective of this study is to evaluate clinical data from CTEPH patients treated with a combination of BPA and selexipag to assess their benefit and to make recommendations for the treatment of CTEPH.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamic changes from baseline (time of diagnosis) 6 months after last BPA
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CTEPH patients treated at the Department of Cardiology, Keio University Hospital from 1 January 2021 to 31 December 2024.
Patients aged 18 or older
Patients with BPA implementation history
Patients receiving selexipag at 6 months after last BPA procedure
Key exclusion criteria
Patients who have requested that their information not be used by the patient or his/her family
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Ieda |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
1608582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-5363-3373
mieda@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
03-5363-3373
Homepage URL
atsushi_anzai@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Nippon Shinyaku Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi Shinjuku-ku Tokyo Japan
Tel
03-3353-1211
info-med-keiyaku@adst.keio.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
| 2024 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As exploratory outcomes, the change from baseline in hemodynamics, blood test, pulmonary function test and WHO functional class at the time point before the first BPA in patients who were started on selexipag prior to BPA. And adverse events and BPA complications are assessed as safety outcomes.
Management information
Registered date
| 2024 | Year | 11 | Month | 18 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064150
