chronic thromboembolic pulmonary hypertension
Conditions
Interventions
The study subjects take selexipag in accordance with a package insert as follows.
The dose adjustment period 12 weeks
-After clinical examination at Visit 1 (baseline), orally administration of
selex
Sponsors
Hiromi Matsubara
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who meet CTEPH diagnostic criteria (complying with 2017 Japanese Cardiovascular Society Guidelines diagnostic criteria) 2) Patients who are ineligible for pulmonary endarterectomy (PEA) 3) Patients who received BPA once or more and passed more than 90 days after BPA treatment 4) Patients who provided a written consent 5) Patients with WHO-FC II or III at the time of enrollment 6) Patients are 18 years of age or older, and 84 years of age or younger at the time of obtaining consent 7) Patients with resting mPAP over 20 mmHg and less than 25 mmHg at the time of enrollment.
Exclusion criteria
Exclusion criteria: 1) Patients with pulmonary hypertension other than class 4 by NICE classification 2) Patients who have difficulty in cardiopulmonary exercise test (CPET) 3) Patients who have severe right heart failure requiring cardiotonic drug 4) Patients with severe cardiac disease 5) Patients with systolic blood pressure less than 90 mmHg at screening 6) Patients with shunt disease 7) Patients with life expectancy less than 2 years 8) Patients who are pregnant or breastfeeding 9) Patients with administration contraindication for selexipag 10) Patients with severe kidney damage (glomerular filtration rate: less than 30mL/min/1.73m2) including patient receiving dialysis 11) Patients who are using other unapproved drugs 12) Patients who have used the pulmonary vasodilator within 60 days before a baseline measurement day 13) Patients with cardiac index (CI) >3 L/min/m2 by thermodilution and estimated Fick's method at enrollment 14) Patients who are judged to be unsuitable as a subject in this study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mPAP/CO slope during CPET from baseline to 24 weeks after selexipag administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Changes in hemodynamics indices during CPET from baseline to 24 weeks after selexipag administration (at the point of 20W level, peak level) 2)Changes in respiratory function indices during CPET from a baseline to 24 weeks after selexipag administration (at rest, at the point of 20W level and peak level) 3)Changes in hemodynamics indices at rest from a baseline to 24 weeks after selexipag administration 4)Changes in transthoracic echocardiography indices from a baseline to 24 weeks after selexipag administration 5)Change in lung perfusion scintigraphy indices from a baseline to 24 weeks after selexipag administration 6)Changes in MRI indices from a baseline to 24 weeks after selexipag administration 7)Change in BNP from a baseline to 24 weeks after selexipag administration 8)Changes in spirometry indices from a baseline to 24 weeks after selexipag administration 9)Change in 6MWD and Borg scale from a baseline to 24 weeks after selexipag administration 10)Change in WHO-FC from a baseline to 24 weeks after selexipag administration 11)Change in emPHasis-10 from a baseline to 24 weeks after selexipag administration 12)Adverse events and drug-related adverse events | — |
Contacts
Public ContactYanagihara Miki
National Hospital Organization Okayama Medical Center
Outcome results
None listed