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

• Conditions: Cardiac Surgery, Separation from cardiopulmonary bypass; MedDRA version: 9.1Level: LLTClassification code 10063082Term: Acute right ventricular failure

• Registration Number: EUCTR2006-002907-15-DE
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

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).
Females can only participate in the study if they are postmenopausal, naturally amenorrheic for at least 1 year, surgically sterile or practicing a reliable method of contraception.

Reliable methods of contraception, which must be used for the entire duration of the study and for at least 3 months after last study drug intake are:

·Intrauterine devices
·Oral, injectable, transdermal or implantable hormonal contraceptives only in combination with a barrier method (e.g., female condom, diaphragm, contraceptive sponge) or use of a condom by her partner.
·Hormone-based contraceptives alone, regardless of the route of administration, are not considered as reliable methods of contraception.
·Abstention, rhythm method, and contraception by the partner alone are not acceptable methods 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:
oSurgery on two valves
oSurgery on one valve plus revascularization
oRe-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
osPAP > 60 mmHg with mPAP/MAP > 0.5
or
osPAP > 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Sitting systolic blood pressure < 100 mmHg (measured at hospital admission).

·Significant chronic lung disease that might interfere with the ability to interpret the study results (e.g., severe chronic obstructive pulmonary disease).

·Emergency surgery.

·Pregnant or breast-feeding females.

·Use of another investigational drug within 28 days prior to randomization.

·Complex adult congenital heart disease.

·Severe concomitant illness limiting life expectancy (< 6 months).

·Participation in a device study that will affect the outcome of the study.

·Pre-operative use of balloon pump.

·Pre-operative use of inotropes/vasopressor drugs.

·Pre-operative treatment of pulmonary arterial hypertension (PAH).

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

·Severe liver impairment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified