Clinical Trial: Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis - a Prospective Double Blind Randomized Controlled Clinical Study

Brief Summary: The most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is the hepatopulmonary syndrome (HPS) with a reported prevalence of 20-47% in patients with hepatic impairment and cirrhosis. HPS is by far the most frequent respiratory complication of cirrhosis. It is a progressive disease leading to significantly increased mortality. Up to date, the only therapeutic option is liver transplantation. The study hypothesis is that administration of bosentan in patients with liver cirrhosis suffering from hepatopulmonary syndrome improves gas exchange. 18 patients with liver cirrhosis fulfilling criteria of HPS according to the ERS task force criteria will be included in this block randomized, double-blind, placebo controlled study (12 patients will be treated with bosentan, 6 with placebo). Patients will receive bosentan 62,5mg b.i.d. for 4 weeks and 125 mg b.i.d. for 8 weeks or placebo. The duration of the treatment phase of the study is 12 weeks. The primary endpoint is the alteration of gas exchange after 3 months of therapy. The expected duration of the study is 2 years.

Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: alveolar-arterial oxygen gradient in mmHg [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • presence of HPS [ Time Frame: 3 months ]
    assessment via contrast enhanced transthoracic echocardiography and pulmonary function testing
  • 6 minutes walking distance in m [ Time Frame: 3 months ]
  • WHO functional class [ Time Frame: 3 months ]
  • quality of life [ Time Frame: 3 months ]
    we will us the CAT-questionaire for QoL assessment
  • aminotransferase level (ASAT, ALAT) [ Time Frame: 3 months ]
    Assessment of the aminotransferase levels in U/L
  • exhanled nitric oxide in parts per billion [ Time Frame: 3 months ]
  • hepatic venous pressure gradient (HVPG) in mmHg [ Time Frame: 3 months ]
    HVPG will be assessed after inclusion in the study and after 3 months
  • pulmonary hemodynamics [ Time Frame: 3 months ]
    pulmonary hemodynamics will be assessed after inclusion and after 3 months
  • mean arterial blood pressue in mmHg [ Time Frame: 3 months ]
  • partial pressure of arterial oxygen in mmHg [ Time Frame: 3 months ]


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: October 26, 2011
Date Started: October 2011
Date Completion:
Last Updated: September 27, 2016
Last Verified: September 2016