Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Valentin Fuhrmann, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01518595
First received: October 26, 2011
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Hepatopulmonary Syndrome
Liver Cirrhosis
Drug: bosentan
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis - a Prospective Double Blind Randomized Controlled Clinical Study

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • alveolar-arterial oxygen gradient in mmHg [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • presence of HPS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    assessment via contrast enhanced transthoracic echocardiography and pulmonary function testing

  • 6 minutes walking distance in m [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • WHO functional class [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    we will us the CAT-questionaire for QoL assessment

  • aminotransferase level (ASAT, ALAT) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Assessment of the aminotransferase levels in U/L

  • exhanled nitric oxide in parts per billion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • hepatic venous pressure gradient (HVPG) in mmHg [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    HVPG will be assessed after inclusion in the study and after 3 months

  • pulmonary hemodynamics [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    pulmonary hemodynamics will be assessed after inclusion and after 3 months

  • mean arterial blood pressue in mmHg [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • partial pressure of arterial oxygen in mmHg [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: October 2011
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Patients will receive placebo tablets twice daily for 3 months.
Drug: Placebo
pts. will receive placebo for 3 months
Active Comparator: bosentan
pts. will receive bosentan for 3 months
Drug: bosentan
pts. will receive bosentan for 3 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of HPS
  • Age ≥ 18 years

Exclusion Criteria:

  • Intracardiac shunting
  • Pregnancy
  • Known hypersensitivity to bosentan
  • Use of glyburide
  • Use of cyclosporin A
  • Elevation of aminotransferase level of > 3 times the upper limit of normal
  • Use of rifampicin
  • Females of childbearing potential without use of adequate contraception
  • Systolic blood pressure < 85 mmHg
  • Clinical relevant anemia
  • HIV-infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518595

Contacts
Contact: Valentin H Fuhrmann, MD 0043140404004741 valentin.fuhrmann@meduniwien.ac.at

Locations
Austria
Medical University Vienna, Dpt. of Internal Medicine 3, Div. of Gastroenterology and Hepatology Recruiting
Vienna, Austria, 1090
Contact: Valentin H Fuhrmann, MD         
Principal Investigator: Valentin H Fuhrmann, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Valentin H Fuhrmann, MD Medical University Vienna
  More Information

No publications provided

Responsible Party: Valentin Fuhrmann, MD, Associate Professor of Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01518595     History of Changes
Other Study ID Numbers: 1-Fuhrmann
Study First Received: October 26, 2011
Last Updated: January 31, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
patients

Additional relevant MeSH terms:
Syndrome
Liver Cirrhosis
Hepatopulmonary Syndrome
Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014