Chronic thromboembolic pulmonary hypertension Chronic thromboembolic pulmonary hypertension
Conditions
Interventions
Participants will be randomly assigned in a 1:1 ratio to either the group continuing selexipag treatment or the group discontinuing selexipag. Participants allocated to the discontinuation group will
Sponsors
Ogo Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are 18 years of age or older at the time of informed consent acquisition 2) Patients with a confirmed diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) 3) Patients who have undergone one or more sessions of balloon pulmonary angioplasty (BPA) 4) Patients who initiated selexipag therapy prior to the final BPA session and continued treatment thereafter 5) Patients whose mean pulmonary arterial pressure (mPAP) was less than 25 mmHg, as measured by right heart catheterization performed at least three months after the final BPA session 6) Patients who have provided written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who have received pulmonary vasodilators other than selexipag within 30 days prior to obtaining informed consent 2) Patients who are listed for lung transplantation or are expected to undergo listing 3) Patients undergoing hemodialysis or peritoneal dialysis 4) Pregnant or lactating women, or women who do not agree to use contraception during the study period 5) Patients deemed ineligible for study participation by the principal investigator or sub-investigator for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in pulmonary vascular resistance (PVR) at Week 24 after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline at Week 24 after randomization in the following parameters: 1) Subjective symptoms (WHO-FC: World Health Organization functional class) 2) Six-minute walk test (6-minute walk distance) 3) Blood biomarkers (BNP: brain natriuretic peptide) 4) Quality of life (PAH-SYMPACT) 5) Hemodynamic parameters assessed by right heart catheterization: Mean pulmonary arterial pressure (mPAP), Pulmonary arterial wedge pressure (PAWP), Right atrial pressure (RAP), Cardiac index (CI), Mixed venous oxygen saturation (SvO2), Arterial oxygen saturation (SaO2) 6) Cardiopulmonary exercise testing parameters: Percent predicted peak oxygen uptake (%peak VO2), Percent predicted anaerobic threshold (%AT), Ventilatory equivalent for carbon dioxide (VE/VCO2) 7) Cardiac MRI findings: Right ventricular end-diastolic volume index (RVEDVI), Right ventricular end-systolic volume index (RVESVI), Right ventricular ejection fraction (RVEF) | — |
Contacts
Public ContactHiroyuki Endo
National Cerebral and Cardiovascular Center
Outcome results
None listed