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Ambrisentan for Treatment of Portopulmonary Hypertension

Information source: Medical University of Graz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Portopulmonary Hypertension

Intervention: ambrisentan (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Medical University of Graz

Official(s) and/or principal investigator(s):
Rudolf E. Stauber, MD, Principal Investigator, Affiliation: Gastroenterology & Hepatology
Horst Olschewski, MD, Study Director, Affiliation: Pulmonology

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.

Clinical Details

Official title: Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: pulmonary vascular resistance

Secondary outcome:

mean arterial pulmonary pressure

hepatic venous pressure gradient

exercise capacity

quality of life

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Medical University of Graz, Graz 8036, Austria; Recruiting
Rudolf Stauber, MD, Phone: +43-316-385-80268, Email: rudolf.stauber@medunigraz.at
Horst Olschewski, MD, Phone: +43-316-385-13305, Email: horst.olschewski@medunigraz.at
Rudolf Stauber, MD, Principal Investigator
Additional Information

Starting date: July 2012
Last updated: December 26, 2013

Page last updated: August 23, 2015

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