A Phase 1/2 interventional study of ambrisentan in Portopulmonary Hypertension, sponsored by Medical University of Graz. Withdrawn at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-17.
Sponsored by Medical University of Graz · Phase 1/2, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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.
Also known as: Volibris
pulmonary vascular resistance
Time frame: week 24
mean arterial pulmonary pressure
Time frame: week 24
hepatic venous pressure gradient
Time frame: week 24
exercise capacity
Time frame: week 24, 48
quality of life
Time frame: week 24, 48
This study is withdrawn, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Medical University of Graz