Improved low-risk criteria scores for combination therapy of sildenafil and generic bosentan in patients with congenital heart disease with severe pulmonary hypertensio

Phase 3

Completed

• Conditions: In Thailand, bosentan and other endothelin receptor antagonists have been considered as second- line add- on therapy to sildenafil, because of its high cost since 2008 (5, 10). A retrospective evaluatio; bosentan in congenital heart disease

• Registration Number: TCTR20200506006
• Lead Sponsor: Medline CO.LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-02-28
• Study Start: 2020-05-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the hemodynamic parameters at baseline and at 3-month intervals 3 month wood unitm2

Secondary Outcome Measures

Name	Time	Method
low risk score 12 months score unit