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A Retrospective Study to Evaluate the Effectiveness and Safety of Selexipag for the Treatment of Pulmonary Arterial Hypertension

A Retrospective Study to Evaluate the Effectiveness and Safety of Selexipag for the Treatment of Pulmonary Arterial Hypertension

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300067393
Enrollment
Unknown
Registered
2023-01-06
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-05-15

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

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diagnosed with pulmonary hypertension (ICD code: I27.0): (1) Idiopathic pulmonary arterial hypertension (IPAH); (2) Hereditary pulmonary arterial hypertension (HPAH); (3) Drug and poison related pulmonary hypertension; (4) Disease-related pulmonary hypertension: 1) Connective tissue disease (CTD); 2) Congenital heart disease; 3) Age >= 18 years old at the time of first treatment with Selexipag tablets; 2. The patient has used Selexipag tablets for >= 90 days, and has dose titration records (all recorded dose changes, including but not limited to: starting dose and date and maximum tolerated dose and date); 3. WHO functional classification II and III.

Exclusion criteria

Exclusion criteria: 1. Pulmonary hypertension patients with PAHWHO function grade IV; 2. Pulmonary hypertension with pulmonary veno-occlusive disease (PVOD)/pulmonary capillary haemangiomatosis (PCH); 3. Patients with moderate or severe obstructive pulmonary disease; 4. Patients with moderate or severe restrictive lung disease; 5. Patients with moderate or severe liver damage (Child-Pugh classification B and C); 6. Patients with left ventricular dysfunction; 7. Patients with severe renal insufficiency; 8. Patients with severe cardiovascular disease (coronary heart disease or unstable angina, myocardial infarction in the last 6 months, decompensated heart failure without close monitoring, severe arrhythmia); 9. Cerebrovascular events (such as transient ischemic attack, stroke) occurred within 3 months before enrollment; 10. Congenital or acquired valve defects related to myocardial functional diseases and not related to pulmonary hypertension; 11. Combined use of strong CYP2C8 inhibitors (such as gemfibrozil); 12. Patients who have used Selexipag tablets in the past and have stopped using them (before the study) or patients who have used Selexipag tablets in clinical trials before; 13. Those who have participated in clinical trials within one month before enrollment; 14. Those who are known to be allergic to the study drug or similar drugs, or have a history of allergic diseases or allergic constitution; 15. Female patients during lactation and pregnancy; 16. Patients with incomplete key clinical data, or other factors considered by the investigator to be unsuitable for participating in this study; 17. Patients with other primary malignant tumors.

Design outcomes

Primary

MeasureTime frame
French Pulmonary Hypertension Network (FPHN) non-invasive risk stratification;

Secondary

MeasureTime frame
WHO Functional class;N-terminal pro-B-type natriuretic peptide;6-minute walking distance;right atrial area;right ventricular diameter;Tricuspid Annular Plane Systolic Excursion (TAPSE);dosage and side effect;

Countries

China

Contacts

Public ContactQiushang Ji

Qilu Hospital of Shandong University

jiqius@aliyun.com+86 185 6008 6588

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026