Status:
TERMINATED
Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Heart Diseases
Hypertension, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 investi...
Detailed Description
Endothelin-1 levels are increased during and after cardiac surgery with cardiopulmonary bypass (CPB), and are associated with many deleterious consequences, including increased pulmonary arterial pres...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00458276
Start Date
April 1 2007
End Date
March 1 2008
Last Update
July 9 2018
Active Locations (33)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
Columbia University Medical Center
New York, New York, United States, 10032
3
Montefiore Medical Center/Albert Einstein College of Medicine
New York, New York, United States, 10467
4
Duke University Medical Center
Durham, North Carolina, United States, 27710