Bosentan improves clinical Outcome of adults with congenital heart disease or mitral valve lesions who undergo CArdiac surgery
Completed
- Conditions
- aangeboren hartafwijkingopen hart operatie risico1004697310007510
- Registration Number
- NL-OMON36241
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
Adults with CHD or with mitral valve lesions who undergo cardiac surgery.
Exclusion Criteria
* Current treatment with bosentan
* Systemic arterial pressure < 85 mmHg
* Incapable of giving informed consent
* Ejection fraction below 30 %
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint of the study is the exercise capacity (peak V*O2) six weeks<br /><br>post-operatively. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints of the study are 1) on the intensive care unit a)<br /><br>hemodynamics b) Sequential Organ Failure Assessment (SOFA) score and c) hours<br /><br>of hospitalization 2) at discharge the right ventricular function (assessed by<br /><br>transthoracic echocardiography) 3a) six weeks post-operatively the right<br /><br>ventricular function (assessed by transthoracic echocardiography) b) the<br /><br>quality of life 4) twelve weeks post-operatively a) right ventricular function<br /><br>(assessed by transthoracic echocardiography) b) differences in clinical status<br /><br>and symptoms</p><br>