Ambrisentan for Treatment of Portopulmonary Hypertension
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.
|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|
- pulmonary vascular resistance [ Time Frame: week 24 ] [ Designated as safety issue: No ]
- 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 ]
|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)|
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.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733095
|Medical University of Graz||Recruiting|
|Graz, Austria, 8036|
|Contact: Rudolf Stauber, MD +43-316-385-80268 firstname.lastname@example.org|
|Contact: Horst Olschewski, MD +43-316-385-13305 email@example.com|
|Principal Investigator: Rudolf Stauber, MD|
|Principal Investigator:||Rudolf E. Stauber, MD||Gastroenterology & Hepatology|
|Study Director:||Horst Olschewski, MD||Pulmonology|