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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056006

Enrollment

Registered

2024-10-31

Start date

2024-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Individuals aged 18 or older who meet the diagnostic criteria for PAH on right heart catheterization at rest and who have hypoxemia associated with lung diseases such as chronic obstructive pulmonary disease, interstitial pneumonia, or mixed restrictive and obstructive disorders; or with conditions like sleep-disordered breathing, alveolar hypoventilation syndrome, chronic high-altitude exposure, or developmental disorders. Patients are either receiving selexipag treatment or are being considered for it.

Exclusion criteria

Exclusion 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).

Design outcomes

Primary

Measure	Time frame
The changes in pulmonary vascular resistance (PVR) and 6-minute walk distance (6MWD) from baseline six months after initiating treatment with selexipag.	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactTakahiro Hiraide

Keio University School of Medicine Department of Cardiology

t.hiraide.a6@keio.jp03-5363-3373

Outcome results