WithdrawnPhase 1/2

Ambrisentan for Treatment of Portopulmonary Hypertension

Stopped: slow recruitment

Austria0Started 2012-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

pulmonary vascular resistance

Timeframe: week 24

Trial details

NCT IDNCT01733095

SponsorMedical University of Graz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04

View on ClinicalTrials.gov More Portopulmonary Hypertension trials