Pulmonary arterial hypertension
Conditions
Interventions
Dose: macitentan 10 mg/day+riociguat 3 mg/day. Max dose of riociguat is 7.5 mg/day.Intervention period: 8 month
Dose: macitentan 10 mg/day+selexipag 0.4 mg/day. Max dose of selexipag is 3.2 mg/day. In
Sponsors
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Mean pulmonary artery pressure greater than 25 mmHg and pulmonary artery wedge pressure less than 15 mmHg and pulmonary vascular resistance greater than 3 wood units within one month after giving consent 2) WHO-FC II or III 3) Age greater than 20 years at the time of giving consent 4) Patients who agree to be enrolled in the study with signed written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients without PAH 2) Patients treated with PAH-specific drugs 3) Patients treated with incompatible drug combination 4) Patients with bleeding or risk of bleeding 5) Patients with pregnancy or suspected pregnancy or patients with breast-feeding 6) Patients with atrial fibrillation 7) Patients with moderate renal dysfunction (serum creatinine 1.5 mg/dl) 8) Patients with moderate liver dysfunction (serum AST or ALT 2-fold of standard value)9) Patients with hypotension (systolic blood pressure less than 90 mmHg) 10) Patients with low cardiac output (cardiac index less than 2.0 l/min/m2 11) Patients included other clinical study 12) Patients recognized as inappropriate by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of change ratio of pulmonary vascular resistance eight month after the administration between two groups | — |
Countries
Japan
Contacts
Public ContactSatoshi Akagi
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science Department of Cardiovascular Medicine
Outcome results
None listed