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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00570622
First received: December 10, 2007
Last updated: November 24, 2008
Last verified: November 2008
History of Changes
  Purpose

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
Cirrhosis
Ascites
Portal Hypertension
 Drug: Pioglitazone
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pioglitazone on Portal and Systemic Hemodynamics in Patients With Advanced Cirrhosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

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

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

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
Active Comparator: 1
Patients receive 60mg of pioglitazone once a day orally for 9 days
 Drug: Pioglitazone
Patients receive 60mg of pioglitazone once a day orally for 9 days
Placebo Comparator: 2
Patients receive Placebo orally once a day for 9 days
 Drug: Placebo
Patients receive placebo once a day orally for 9 days

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570622

Locations
Austria
Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Arnulf Ferlitsch, MD Medical University of Vienna
  More Information

Publications:

Responsible Party: Arnulf Ferlitsch, MD, Gastroenterology and Hepatology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00570622     History of Changes
Other Study ID Numbers: CIRRPIO
Study First Received: December 10, 2007
Last Updated: November 24, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Cirrhosis
oxidative stress
pioglitazone

Additional relevant MeSH terms:
Ascites
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Pathologic Processes
Vascular Diseases
 Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013