Tokyo, April 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061188) titled 'A Prospective Single-Arm Study of Sotatercept for Safe Discontinuation of Parenteral Prostacyclin Therapy: HEalth Outcomes and REmission in Low-Risk Pulmonary Arterial Hypertension' on April 7.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kyorin University School of Medicine
Condition:
Condition - pulmonary arterial hypertension
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study is an exploratory, prospective study designed to investigate whether the gradual reduction and discontinuation of prostacyclin-based injectable medications can be safely implemented in PAH patients who have maintained a low-risk status (REVEAL Lite 2 score of 5 or less) for at least 3 months while receiving sotatercept.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Reduction and discontinuation of continuous intravenous or subcutaneous administration of prostacyclin analogs during treatment with sotatercept
Eligibility:
Age-lower limit - 18
years-old
40 mmHg at enrollment
3. Patients who required hospitalization or intensified treatment for PAH within 3 months prior to enrollment
4. Patients with serious comorbidities (e.g., severe liver or kidney dysfunction, uncontrolled heart disease, or infections)
5. Women who are pregnant, breastfeeding, or planning to become pregnant during study participation
6. Cases where the principal investigator or a co-investigator determines that participation in this study is inappropriate
7. Patients with mPAP <25 mmHg and PAP/CO slope <3 (based on iCPET)
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 28 Day
Date of IRB - 2026 Year 03 Month 06 Day
Anticipated trial start date - 2026 Year 05 Month 11 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069817
Disclaimer: Curated by HT Syndication.
