A non-interventional observational study evaluating the efficacy and safety of selexipag in pulmonary arterial hypertension with coexisting lung disease

UMIN ID: UMIN000056006

Registered date:31/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary arterial hypertension
• Date of first enrollment: 2024/11/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The changes in pulmonary vascular resistance (PVR) and 6-minute walk distance (6MWD) from baseline six months after initiating treatment with selexipag.
• Secondary Outcome: Changes of right heart catheterization parameters other than PVR, blood test findings (complete blood count, general biochemistry (AST, ALT, gGTP, LDH, ALP, total bilirubin, direct bilirubin, indirect bilirubin, BUN, creatinine, eGFR, free T3, free T4, TSH, total protein, albumin, sodium, potassium, chloride, calcium, magnesium, phosphorus), BNP, uric acid level, HbA1c, triglycerides, LDL cholesterol, HDL cholesterol, total cholesterol, high-sensitivity troponin T), echocardiography findings, pulmonary function test results, quality of life questionnaire, clinical observations (blood pressure, pulse, SpO2, respiratory rate, WHO functional class)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients who have not provided consent for the study or for whom selexipag administration is contraindicated (those with a history of hypersensitivity to selexipag, severe hepatic impairment, or pulmonary veno-occlusive disease).

Related Information

• Primary Sponsor: Keio University
• Source(s) of Monetary Support: Nippon Shinyaku Co., Ltd.