Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery
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ClinicalTrials.gov Identifier: NCT00458276 |
Recruitment Status
:
Terminated
(6 month vital status report not collected after 28 day follow up analysis indicated no difference between placebo & tezosentan)
First Posted
: April 10, 2007
Last Update Posted
: February 15, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Diseases Hypertension, Pulmonary | Drug: tezosentan Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 274 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Cardiac Surgery |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Tezosentan
|
Drug: tezosentan
Tezosentan (ACT-050089, Ro 61-0612) as a 1% solution in 0.9% NaCl (i.e., normal saline) for i.v. use.
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Placebo Comparator: 2
Placebo
|
Drug: placebo
Placebo (i.e., normal saline) for i.v. use.
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- The primary objective of this trial is to demonstrate that tezosentan, a dual ERA, reduces the incidence of clinically relevant right ventricular failure in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing CPB. [ Time Frame: During weaning from CPB ]
- Proportion of patients w/a major clinical event w/in 28 days after study drug initiation like death/major cardiovascular events/infections that prolong hospital stay or require re-admission/new onset of renal failure requiring renal replacement therapy [ Time Frame: Within 28 days after study initiation ]
- Time to weaning from cardiopulmonary bypass [ Time Frame: Defined as time from release of cross-clamp to successful weaning from CPB ]
- Time from end of CPB to final discharge from Intensive Care Unit (ICU) [ Time Frame: From end of CPB to final discharge from ICU ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458276

Study Chair: | Andre Denault, Prof. | Montreal Heart Institute | |
Study Chair: | Ronald Pearl, MD | Stanford University | |
Study Chair: | Robert Michler, MD | Montefiore Medical Center | |
Study Chair: | Steven Tsui | Papworth Hospital | |
Study Chair: | Rainald Seitelberger, Prof. | AKH University of Vienna | |
Study Chair: | Andrea D'Armini, Prof. | San Matteo Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Elisabet Lindberg, MD, International Clinical Leader, Actelion |
ClinicalTrials.gov Identifier: | NCT00458276 History of Changes |
Other Study ID Numbers: |
AC-051-350 |
First Posted: | April 10, 2007 Key Record Dates |
Last Update Posted: | February 15, 2010 |
Last Verified: | February 2010 |
Keywords provided by Actelion:
Left sided heart disease Elevated pulmonary arterial pressure Right ventricular failure Cardiac surgery |
heart-lung machine cardiopulmonary bypass tezosentan Actelion |
Additional relevant MeSH terms:
Heart Diseases Hypertension Hypertension, Pulmonary Vascular Diseases Cardiovascular Diseases Lung Diseases |
Respiratory Tract Diseases Tezosentan Epoprostenol Vasodilator Agents Antihypertensive Agents Platelet Aggregation Inhibitors |