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Ambrisentan for Treatment of Portopulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01733095
Recruitment Status : Withdrawn (slow recruitment)
First Posted : November 26, 2012
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Portopulmonary Hypertension Drug: ambrisentan Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study
Study Start Date : July 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ambrisentan

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. pulmonary vascular resistance [ Time Frame: week 24 ]

Secondary Outcome Measures :
  1. mean arterial pulmonary pressure [ Time Frame: week 24 ]
  2. hepatic venous pressure gradient [ Time Frame: week 24 ]
  3. exercise capacity [ Time Frame: week 24, 48 ]
  4. quality of life [ Time Frame: week 24, 48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733095


Locations
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Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Rudolf E. Stauber, MD Gastroenterology & Hepatology
Study Director: Horst Olschewski, MD Pulmonology
More Information
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01733095    
Other Study ID Numbers: PoPH-GRZ ambrisentan
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Ambrisentan
Antihypertensive Agents