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Ambrisentan for Treatment of Portopulmonary Hypertension
This study has been withdrawn prior to enrollment.
(slow recruitment)
Sponsor:
Medical University of Graz
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01733095
First received: November 20, 2012
Last updated: June 16, 2016
Last verified: June 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Portopulmonary Hypertension | Drug: ambrisentan | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study |
Resource links provided by NLM:
Further study details as provided by Medical University of Graz:
Primary Outcome Measures:
- pulmonary vascular resistance [ Time Frame: week 24 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 0 |
| Study Start Date: | July 2012 |
| Study Completion Date: | June 2016 |
| Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
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.
Other Name: Volibris
|
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733095
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733095
Locations
| Austria | |
| Medical University of Graz | |
| Graz, Austria, 8036 | |
Sponsors and Collaborators
Medical University of Graz
Investigators
| Principal Investigator: | Rudolf E. Stauber, MD | Gastroenterology & Hepatology |
| Study Director: | Horst Olschewski, MD | Pulmonology |
More Information
| Responsible Party: | Medical University of Graz |
| ClinicalTrials.gov Identifier: | NCT01733095 History of Changes |
| Other Study ID Numbers: |
PoPH-GRZ ambrisentan |
| Study First Received: | November 20, 2012 |
| Last Updated: | June 16, 2016 |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 20, 2017