| December 10, 2007 |
| November 24, 2008 |
| December 2004 |
| November 2008 (final data collection date for primary outcome measure) |
| portal and systemic hemodynamic parameters [ Time Frame: 9 days ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00570622 on ClinicalTrials.gov Archive Site |
| markers of oxidative stress (malondialdehyde) [ Time Frame: 9 days ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Effect of Pioglitazone on Portal and Systemic Hemodynamics in Patients With Advanced Cirrhosis |
| Effect of Pioglitazone on Portal and Systemic Hemodynamics in Patients With Advanced Cirrhosis |
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. |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
- Cirrhosis
- Ascites
- Portal Hypertension
|
- Drug: Pioglitazone
- Drug: Placebo
|
- Active Comparator: Patients receive 60mg of pioglitazone once a day orally for 9 days
- Placebo Comparator: Patients receive Placebo orally once a day for 9 days
|
| Ferlitsch A, Pleiner J, Mittermayer F, Schaller G, Homoncik M, Peck-Radosavljevic M, Wolzt M. Vasoconstrictor hyporeactivity can be reversed by antioxidants in patients with advanced alcoholic cirrhosis of the liver and ascites. Crit Care Med. 2005 Sep;33(9):2028-33. |
| |
| Completed |
| 20 |
| November 2008 |
| November 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Cirrhosis, grade B or C (Child-Pugh score)
Exclusion Criteria:
- History of hypersensitivity to the trial drugs and contrast agent or to drugs with a similar chemical structure
- Treatment with vasoactive or non-steroidal anti-inflammatory drugs or systemic antibiotics one week before the study
- Exclusion criteria for hepatic hemodynamic investigation
- Cardiac, renal or respiratory failure
- Previous surgical or transjugular intrahepatic portosystemic shunt
- Insulin-dependent diabetes
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Austria |
| |
| NCT00570622 |
| Arnulf Ferlitsch, MD, Gastroenterology and Hepatology, Medical University of Vienna |
| CIRRPIO |
| Medical University of Vienna |
|
| Principal Investigator: |
Arnulf Ferlitsch, MD |
Medical University of Vienna |
|
|
| Medical University of Vienna |
| November 2008 |
