Ambrisentan for Treatment of Portopulmonary Hypertension

Portopulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01733095
• Other study ID #: PoPH-GRZ ambrisentan
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: November 20, 2012
• Last updated: June 16, 2016
• Start date: July 2012
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hypertension
• Portopulmonary Hypertension

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary vascular resistance		week 24	No
Secondary	mean arterial pulmonary pressure		week 24	No
Secondary	hepatic venous pressure gradient		week 24	No
Secondary	exercise capacity		week 24, 48	No
Secondary	quality of life		week 24, 48	No