UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061502 |
|---|---|
| Receipt number | R000070373 |
| Scientific Title | Prospective Observational Study of Selexipag Assessed by Exercise Cardiovascular Magnetic Resonance in Patients with Chronic Thromboembolic Pulmonary Hypertension After Mechanical Reperfusion |
| Date of disclosure of the study information | 2026/05/09 |
| Last modified on | 2026/05/09 10:24:47 |
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Basic information
Public title
Prospective Observational Study of Selexipag Assessed by Exercise Cardiovascular Magnetic Resonance in Patients with Chronic Thromboembolic Pulmonary Hypertension After Mechanical Reperfusion
Acronym
SELEXCMR-CTEPH
Scientific Title
Prospective Observational Study of Selexipag Assessed by Exercise Cardiovascular Magnetic Resonance in Patients with Chronic Thromboembolic Pulmonary Hypertension After Mechanical Reperfusion
Scientific Title:Acronym
SELEXCMR-CTEPH
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) remains associated with substantial residual functional limitation after mechanical reperfusion. Even following pulmonary endarterectomy (PEA) or balloon pulmonary angioplasty (BPA), only about 30% of patients achieve World Health Organization functional class I. Moreover, the efficacy of selexipag after mechanical reperfusion has not been previously established. Therefore, this study aims to evaluate the therapeutic effects of selexipag using exercise cardiovascular magnetic resonance (exCMR), which enables comprehensive assessment of cardiac function and hemodynamic responses under stress conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in SV, RVEDV/LVEDV, and RVESV/LVESV on exCMR before and after selexipag.
Key secondary outcomes
Change in WHO-FC, 6MWD, CPX parameters, emPHasis-10, and NT-proBNP
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
Patients must be >=18 years old, able to provide informed consent, and receive care for CTEPH at Kyushu University Hospital between study approval and March 31, 2028.
Necessary condition
Reduced exercise capacity (peak VO2 <15 mL/min/kg) with residual pulmonary hypertension (mPAP >20 mmHg), and prior PEA or BPA with no indication for further intervention, requiring pulmonary vasodilator therapy (riociguat or selexipag).
Sufficient condition (at least 1 required)
ï½¥Inadequate response to riociguat after >=90 days (peak VO2 <=15 mL/min/kg and mPAP >20 mmHg)
ï½¥Documented reason not to use riociguat (e.g., hypotension, lung disease, renal dysfunction, adverse effects, or prior inefficacy)
Note
Selexipag initiation is based on clinical indication and is not influenced by the study.
Key exclusion criteria
(1) Unable to undergo MRI, cannot tolerate exercise stress, or otherwise unable to complete the study procedures
(2) Pregnant patients
(3) Dementia
(4) Any patient deemed inappropriate for study participation by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keimei |
| Middle name | |
| Last name | Yoshida |
Organization
Kyushu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
81128582
Address
3-1-1, Maidashi, Higashiku, Fukuoka
TEL
0926425360
yoshida.keimei.713@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Izumi |
Organization
Kyushu University Graduate School of Medicines
Division name
Department of Cardiovascular Medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashiku, Fukuoka
TEL
0926425360
Homepage URL
izumi.ryo.465@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Nihon Shinyaku
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
Center for Clinical and Translational Research, Kyushu University
Address
3-1-1, Maidashi, Higashiku, Fukuoka
Tel
092-642-5082
ijkseimei@jimu.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | 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
| 2025 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing applicable
Management information
Registered date
| 2026 | Year | 05 | Month | 09 | Day |
Last modified on
| 2026 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070373
