Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis
Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.