Effect of Pioglitazone on Portal and Systemic Hemodynamics in Patients With Advanced Cirrhosis - Tabular View

Tracking Information

First Received Date ^ICMJE

December 10, 2007

Last Updated Date

November 24, 2008

Start Date ^ICMJE

December 2004

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

portal and systemic hemodynamic parameters [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00570622 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

markers of oxidative stress (malondialdehyde) [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect of Pioglitazone on Portal and Systemic Hemodynamics in Patients With Advanced Cirrhosis

Official Title ^ICMJE

Effect of Pioglitazone on Portal and Systemic Hemodynamics in Patients With Advanced Cirrhosis

Brief 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.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Investigator)
Primary Purpose:  Treatment

Condition ^ICMJE

Cirrhosis
Ascites
Portal Hypertension

Intervention ^ICMJE

Drug: Pioglitazone
Patients receive 60mg of pioglitazone once a day orally for 9 days
Drug: Placebo
Patients receive placebo once a day orally for 9 days

Study Arms / Comparison Groups

1: Active Comparator
Patients receive 60mg of pioglitazone once a day orally for 9 days

Intervention: Drug: Pioglitazone
2: Placebo Comparator
Patients receive Placebo orally once a day for 9 days

Intervention: Drug: Placebo

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT ID ^ICMJE

NCT00570622

Responsible Party

Arnulf Ferlitsch, MD, Gastroenterology and Hepatology, Medical University of Vienna

Study ID Numbers ^ICMJE

CIRRPIO

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Arnulf Ferlitsch, MD

Medical University of Vienna

Information Provided By

Medical University of Vienna

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP