In Thailand,
Conditions
Interventions
Bosentan add on to sildenafil
Experimental Drug
Sponsors
Medline CO.LTD
Eligibility
Sex/Gender
All
Age
12 Years to 100 Years
Inclusion criteria
Inclusion criteria: : 1) male or female, older than 12 years-of age; 2) patients diagnosed with PAH-CHD, such as Eisenmenger syndrome, PAH with small defect, or PAH after defect correction (We did not include patients with PAH-CHD who were suitable for corrective repair by the 2015 European Society of Cardiology (ESC)/ European Respiratory Society (ERS) pulmonary hypertension (PH) guidelines (4, 9); 3) patients with WHO functional class (1988 WHO functional classification), level I or II who have had a stable disease for at least three months before participating; 4) patients who have had a 6MWD test equal to or greater than 100 m or less than 450 m; 5) patients have not previously been treated with Silkay 125® or any other endothelin receptor antagonist; 6) female patients who are surgically sterile, postmenopausal, or have documented infertility; 7) female patients of childbearing potential using one of the following methods of contraception: barrier-type device (e.g., condom, diaphragm) used only in combination with a spermicide, a double-barrier method is recommended, intrauterine devices (IUDs), or oral or implanted contraceptives, if used in combination with a barrier method; 8) patients providing written informed consent.
Exclusion criteria
Exclusion criteria: The exclusion criteria were: 1) pregnant patients, nursing mothers; 2) patients with left ventricular dysfunction (ejection fraction < 40%); 3) patients with systolic blood pressure less than 85 mm Hg; 4) patients with other conditions that may affect the ability to perform a 6-minute walk distance test; 5) patients with AST/ALT equal to or more than 3-times the upper limit normal; 6) patients with concurrent use of cyclosporine or glyburide; 7) patients unable to provide informed consent or comply with the patient protocol; 8) patients with planned surgical intervention during the study period; 9) patients with known hypersensitivity to bosentan or any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the hemodynamic parameters at baseline and at 3-month intervals 3 month wood unitm2 | — |
Secondary
| Measure | Time frame |
|---|---|
| low risk score 12 months score unit | — |
Countries
Thailand
Outcome results
None listed