Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan is an investigational intravenous drug that blocks the endothelin receptors. This clinical trial will assess the potential benefit of tezosentan compared with placebo in the treatment of patients undergoing open heart surgery with cardiopulmonary bypass (CPB). Treatment time is from the start of surgery up to 24 hours.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion; Idorsia Pharmaceuticals Ltd.
• Treatments: Epoprostenol; Tezosentan

Criteria

Inclusion Criteria:

• Patients ≥ 18 years of age

• Male or female patients (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception).

• Patients undergoing complex* cardiac surgery on CPB and having systolic PAP > 40 mmHg or mean PAP > 30 mmHg (*surgery on 2 valves, 1 valve and revascularization, or reoperation of a valve)

• Patients undergoing cardiac surgery on CPB and having pre-operative pulmonary hypertension due to left heart disease with systolic PAP > 60 mmHg

• Signed written informed consent

Exclusion Criteria:

• Systolic blood pressure < 100 mmHg

• Significant chronic lung disease

• Emergency surgery

• Pregnant/breast-feeding

• Investigational drug use within 28 days prior to randomization

• Complex adult congenital heart disease.

• Severe concomitant illness limiting life expectancy to < 6 months

• Participation in a device study that will affect the outcome of the study

• Pre-operative use of balloon pump, inotropes/vasopressors, treatment of pulmonary arterial hypertension

• Known hypersensitivity to tezosentan or drugs of the same class, or any of their excipients

• Severe liver impairment