Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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, such as bleeding, arrhythmias, and death.Right ventricular failure is another complication, contributing to poor clinical outcome. Right ventricular failure is a clinical syndrome, often difficult to treat, characterized by edema, elevated jugular venous pressure, oliguria, hypotension, and in severe cases shock, multi organ failure and death. Patients with CHD and patients with mitral valve lesions are suspected to be at increased risk for developing right ventricular failure post-operatively. In addition, other clinical factors contributing to right ventricular failure are mechanical pulmonary ventilation, pulmonary hypertension and cardiac surgery. Right ventricular failure during cardiac surgery is caused by the cardiopulmonary bypass by reperfusion with high partial pressures of oxygen, air embolism, and the release of cytokines. The endothelin-1 cytokine induces vasoconstriction of the pulmonary arterioles resulting in right ventricular afterload elevation. Treating patients with an endothelin-1 receptor antagonist might improve clinical outcome post operatively by decreasing right ventricular afterload

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Berto J Bouma
• Treatments: Bosentan

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