Tokyo, May 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061502) titled 'Prospective Observational Study of Selexipag Assessed by Exercise Cardiovascular Magnetic Resonance in Patients with Chronic Thromboembolic Pulmonary Hypertension After Mechanical Reperfusion' on May 9.

Study Type: Observational

Primary Sponsor: Institute - Kyushu University

Condition: Condition - Chronic thromboembolic pulmonary hypertension Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 18 years-old =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 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) ･Inadequate response to riociguat after >=90 days (peak VO2 20 mmHg) ･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 Size - 10

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070373

Disclaimer: Curated by HT Syndication.