Status:
UNKNOWN
Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery
Lead Sponsor:
Berto J Bouma
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cardiac surgery relieves symptoms and increases life expectancy in cardiac patients, with and without congenital heart disease (CHD). However, cardiac surgery involves many risks of complications, suc...
Detailed Description
Rationale: Cardiac surgery relieves symptoms and increases life expectancy in cardiac patients, with and without congenital heart disease (CHD). However, cardiac surgery involves many risks of complic...
Eligibility Criteria
Inclusion
- Adults with CHD or mitral valve lesions who are scheduled for elective cardiac surgery
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01184404
Start Date
September 1 2011
Last Update
December 22 2015
Active Locations (1)
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1
Academic Medical Center
Amsterdam, North Holland, Netherlands, 1105AZ