pulmonale hypertensie pre-operative pulmonary hypertension in cardiac surgery
Conditions
Interventions
Administration of Tezosentan (ACT-050089, Ro 61-0612) as a 1% solution in 0,9%
NaCl for i.v. use.
Sponsors
Actelion Pharmaceuticals
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male or female patients >=18 years of age (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 sPAP > 40 mmHg or mPAP > 30 mmHg (measured by RHC or echocardiography at screening). * Complex cardiac surgery is defined as: - Surgery on two valves - Surgery on one valve plus revascularization - Re-operation of previous valve surgery. ;Or ;Patients undergoing cardiac surgery on CPB and having pre-operative pulmonary hypertension due to left heart disease (measured by RHC or echocardiography at screening) defined as: - sPAP > 60 mmHg with mPAP/MAP > 0.5 or - sPAP > 60 mmHg with signs and/or symptoms of right ventricular dysfunction. - Signed informed consent prior to any study-mandated procedure. ;(MAP = mean arterial pressure; mPAP = mean pulmonary arterial pressure; sPAP = systolic pulmonary arterial pressure; RHC = right heart catheterization.)
Exclusion criteria
Exclusion criteria: - Sitting systolic blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients during weaning from cardiopulmonary bypass, with clinically relevant right ventricular failure defined as absence of or significant reduction of right ventricular wall motion by direct visual inspection peri-operatively and/or severe reduction of right ventricular fraction area change (>20%) measured by 2-D echocardiography, requiring the use of 3 or more inotropic/vasopressor treatments or 2 at high doses, return to CPB, use of rescue therapy for high PAP, use of ventricular assist device or with fatal outcome (all causes, up to 24 hours after start of weaning). Definition of high dose of vasopressor/inotropic drugs: • Dopamine > 5 µg/kg/min • Dobutamine > 5µg/kg/min • Norepinephrine (noradrenalin) > 0.05 µg/kg/min • Epinephrine (adrenalin) > 0.05 µg/kg/min • Milrinone bolus >= 50 µg/kg, and > 0.5 µg/kg/min • Phenylephrine > 2.5 µg/kg/min • Isoproterenol > 0.01 µg/min • Vasopressin at a cumulative dose of > 10 units • Levosimendan > 0.2 µg/kg/min | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints • Proportion of patients with a major clinical event within 28 days after study drug initiation: o Death; or o Major cardiovascular events;* or o Infections that prolong hospital stay or require re-admission; or o New onset of renal failure requiring renal replacement therapy. *Major cardiovascular events: acute pulmonary edema, myocardial infarction, stroke, ventricular arrhythmia requiring cardioversion, cardiogenic shock or cardiac arrest. • Time to weaning from cardiopulmonary bypass (defined as time from release of cross-clamp to successful weaning from CPB). • Time from end of CPB to final discharge from ICU. | — |
Countries
Netherlands
Outcome results
None listed