Effect of Pioglitazone on Portal and Systemic Hemodynamics in Patients With Advanced Cirrhosis
Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis; Ascites; Portal Hypertension
Intervention: Pioglitazone (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s):
Arnulf Ferlitsch, MD, Principal Investigator, Affiliation: Medical University of Vienna
Overall contact:
Arnulf Ferlitsch, MD, Phone: +43140400, Ext: 4741, Email: arnulf.ferlitsch@meduniwien.ac.at
Summary
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
Clinical Details
Official title: Effect of Pioglitazone on Portal and Systemic Hemodynamics in Patients With Advanced Cirrhosis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Primary outcome: portal and systemic hemodynamic parameters
Secondary outcome: markers of oxidative stress (malondialdehyde)
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Arnulf Ferlitsch, MD, Phone: +43140400, Ext: 4741, Email: arnulf.ferlitsch@meduniwien.ac.at
Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna, Vienna 1090, Austria; Recruiting
Arnulf Ferlitsch, MD, Phone: +43140400, Ext: 4741, Email: arnulf.ferlitsch@meduniwien.ac.at
Arnulf Ferlitsch, MD, Principal Investigator
Additional Information
Related publications: 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.
Starting date: December 2004
Ending date: February 2008
Last updated: December 10, 2007
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