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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Heart Diseases, Hypertension, Pulmonary

In brief

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.

Key facts

Study ID

NCT00458276

Run by

Idorsia Pharmaceuticals Ltd.

People needed

274

Starts

2007-04-01

Expected to finish

2008-03-01

Last updated by the study team

2018-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Medical Center/Albert Einstein College of Medicine — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Texas Heart Institute/St. Luke's Episcopal Hospital/Baylor College — Houston, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Medical University of Innsbruck — Innsbruck, Austria
• AKH University of Vienna — Vienna, Austria
• University of Alberta Hospital — Edmonton, Alberta, Canada
• London Health Sciences Centre-University Hospital — London, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Quebec Heart Institute/Hopital Laval — Québec, Quebec, Canada
• Institute for Clinical and Experimental Medicine (IKEM) — Prague, Czechia
• Hopital Pitie Salpetriere — Paris, France
• Deutches Herzzentrum — Berlin, Germany
• Dresden Universitatsklinik/Cardiology Center — Dresden, Germany
• Zentrum der Chirugie-Zchir-des Universitatsklinikums — Frankfurt, Germany
• Narayana Hrudayalaya — Bangalore, India
• Nizam's Institute of Medical Sciences — Hyderabaad, India
• Shaare Zedek Medical Center — Jerusalem, Israel
• Fondazione IRCCS San Matteo Hospital, Cardiac Surgery — Pavia, Italy

Full record on ClinicalTrials.gov

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