Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT01184404
Eligibility Criteria:
Inclusion Criteria:
* Adults with CHD or mitral valve lesions who are scheduled for elective cardiac surgery
Exclusion Criteria:
* Current treatment with bosentan
* Systemic arterial pressure \< 85 mmHg
* Incapable of giving informed consent
* Hypersensitivity to bosentan or any of its help substances
* Moderate to severe liver disease: Child-Pugh class B or C
* Raised plasma transaminases level \> three times limiting value.
* Simultaneous use of cyclosporine A
* Percutaneous Transluminal Angioplasty procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01184404
Study Brief:
Protocol Section:
NCT01184404