Ambrisentan for Treatment of Portopulmonary Hypertension
- Registration Number
- NCT01733095
- Lead Sponsor
- Medical University of Graz
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ambrisentan 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.
- Primary Outcome Measures
Name Time Method pulmonary vascular resistance week 24
- Secondary Outcome Measures
Name Time Method hepatic venous pressure gradient week 24 mean arterial pulmonary pressure week 24 exercise capacity week 24, 48 quality of life week 24, 48
Trial Locations
- Locations (1)
Medical University of Graz
🇦🇹Graz, Austria