Ambrisentan for Treatment of Portopulmonary Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01733095
First received: November 20, 2012
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

Portopulmonary hypertension denotes pulmonary hypertension complicating portal hypertension and is present in approximately 5% of cirrhotic patients. Treatment options include prostanoids, sildenafil, and the endothelin-receptor antagonists, bosentan and ambrisentan.

This study investigates the safety and efficacy of ambrisentan in portopulmonary hypertension.


Condition Intervention Phase
Portopulmonary Hypertension
Drug: ambrisentan
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • pulmonary vascular resistance [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean arterial pulmonary pressure [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • hepatic venous pressure gradient [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • exercise capacity [ Time Frame: week 24, 48 ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: week 24, 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ambrisentan
In all patients with clinically significant PoPH, ambrisentan will be administered orally using a low ascending dose regime (see below). Duration of treatment will be 12 months.
Drug: ambrisentan
Ambrisentan (Volibris 5 mg film-coated tablets, Glaxo Smith-Kline) will be started at 5 mg every other day and increased to 5 mg daily after 4 weeks if tolerated well.
Other Name: Volibris

Detailed Description:

Patients with clinically significant PoPH (resting mean pulmonary arterial pressure >25 mm Hg, pulmonary vascular resistance >400 dynes*s*cm-5) will be offered treatment with ambrisentan. Patients will be followed clinically and hemodynamically up to 12 months after start of treatment.

  Eligibility

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

Inclusion Criteria:

  • Adult patients with portal hypertension, age >18 years
  • Cirrhosis of any etiology; Child-Pugh class A and B
  • Noncirrhotic portal hypertension (e.g. chronic portal vein thrombosis)
  • Informed consent

Exclusion Criteria:

  • Presence of other causes for pulmonary arterial hypertension
  • History of pulmonary embolism or myocardial infarction within 6 months before study start
  • Child-Pugh class C
  • Presence of hepatocellular carcinoma
  • Liver transplantation
  • HIV infection
  • Severe obstructive or restrictive pulmonary disease (predicted FEV1 or VC <65%, respectively)
  • Severe dilated cardiomyopathy (EF <50%)
  • Latent left-heart insufficiency
  • Pregnancy and lactation
  • Esophageal variceal hemorrhage within the last 6 months
  • Refractory ascites
  • Hepatorenal syndrome
  • Persistent hepatic encephalopathy > grade 1
  • Bilirubin >3.0 mg/dl
  • AST and/or ALT >3x ULN
  • Creatinine >2.0 mg/dl
  • Known hypersensitivity to ambrisentan
  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: NCT01733095

Locations
Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Rudolf Stauber, MD    +43-316-385-80268    rudolf.stauber@medunigraz.at   
Contact: Horst Olschewski, MD    +43-316-385-13305    horst.olschewski@medunigraz.at   
Principal Investigator: Rudolf Stauber, MD         
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Rudolf E. Stauber, MD Gastroenterology & Hepatology
Study Director: Horst Olschewski, MD Pulmonology
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01733095     History of Changes
Other Study ID Numbers: PoPH-GRZ ambrisentan
Study First Received: November 20, 2012
Last Updated: December 26, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014