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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00570622 |
The purpose of this study is to investigate the response to pioglitazone on the hepatic venous pressure gradient and peripheral vascular responsiveness to vasoconstrictors in patients with advanced (Child´s Grade B or C) cirrhosis.
Condition | Intervention | Phase |
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Cirrhosis Ascites Portal Hypertension |
Drug: Pioglitazone Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Effect of Pioglitazone on Portal and Systemic Hemodynamics in Patients With Advanced Cirrhosis |
Enrollment: | 20 |
Study Start Date: | December 2004 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Patients receive 60mg of pioglitazone once a day orally for 9 days
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Drug: Pioglitazone
Patients receive 60mg of pioglitazone once a day orally for 9 days
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2: Placebo Comparator
Patients receive Placebo orally once a day for 9 days
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Drug: Placebo
Patients receive placebo once a day orally for 9 days
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Cirrhotic liver disease is associated with portal hypertension including elevated portal pressure as well as hyperdynamic circulation and low peripheral vascular resistance. Endothelial nitric (NO) release is impaired in liver microvasculature, upregulation of eNOS activity in the cirrhotic liver may constitute a new strategy to correct the increased hepatic vascular tone in these patients. In contrary to this impaired endothelium-dependent relaxation (endothelial dysfunction) and NO deficiency in the cirrhotic liver, systemic and splanchnic circulation of cirrhotic patients is characterized by increased vascular tone and hyporesponsiveness to vasoconstrictors. In addition to increasing insulin sensitivity, thiazolidinediones, like pioglitazone decrease oxidative stress and inflammation and improve endothelial function. In a randomized controlled, parallel group double-blind study 20 Patients with advanced (Child´s Grade B or C) liver cirrhosis will receive pioglitazone or placebo for nine days. Portal hemodynamics and forearm blood flow response will be measured at baseline and after pioglitazone/placebo to investigate the effect of pioglitazone in these group of patients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna | |
Vienna, Austria, 1090 |
Principal Investigator: | Arnulf Ferlitsch, MD | Medical University of Vienna |
Responsible Party: | Gastroenterology and Hepatology, Medical University of Vienna ( Arnulf Ferlitsch, MD ) |
Study ID Numbers: | CIRRPIO |
Study First Received: | December 10, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00570622 |
Health Authority: | Austria: Ethikkommission |
Cirrhosis oxidative stress pioglitazone |
Liver Diseases Digestive System Diseases Pioglitazone Fibrosis Ascites Vascular Diseases |
Stress Hypertension, Portal Liver Cirrhosis Portal hypertension Hypertension |
Hypoglycemic Agents Pathologic Processes Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |