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

Phase 3

Withdrawn

• Conditions: pulmonale hypertensie; 10019280; pre-operative pulmonary hypertension in cardiac surgery; 10007593

• Registration Number: NL-OMON31244
• Lead Sponsor: Actelion Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 10

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

- 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
• Study Design: Not specified