Table 2 Secondary endpoints, exploratory endpoint and safety evaluation that will be measured and/or compared at baseline and at 12 months after initiation of treatment
Secondary endpoints | |
|---|---|
Change in hemodynamic variables | mean pulmonary arterial pressure, cardiac output, etc. |
Change in 6-min walk distance | |
Change in WHO functional class | |
Change in plasma NT-proBNP level | |
Change in echocardiography | tricuspid annulus systolic displacement (TAPSE), right atrium area, right ventricle size, eccentricity index, pericardial effusion |
Change in Borg dyspnea index | |
Change in quality-of-life parameters (SF 36) | |
Exploratory endpoint | |
cardiopulmonary exercise testing | |
cardiac magnetic resonance | |
Safety evaluation | |
Frequency of adverse events | hemoptysis/pulmonary hemorrhage (vascular perforation, vascular dissection, vascular rupture, etc), pneumothorax, hypotension, pulmonary congestion/ pulmonary edema, late-onset lung disturbance, heart failure, pneumonia, headache, dizziness, peripheral edema, nausea/vomiting, retching, diarrhea, nasopharyngitis, upper respiratory inflammation, respiratory distress, coughing and fainting |
Clinical worsening during the observation period and time to clinical worsening | All-cause mortality, heart/lung transplant, hospitalization due to clinical worsening, new initiation of pulmonary hypertension target medications, worsening of 30% or greater from baseline in the 6MWD and persistent worsening in the WHO FC from baseline due to the worsening of a primary disease. |
Laboratory tests | hemoglobin, alanine aminotransferase, creatinine, aspartate aminotransferase |