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

NCT ID: NCT00570622

Last Updated: 2008-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Cirrhosis Ascites Portal Hypertension

Keywords

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Cirrhosis oxidative stress pioglitazone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Patients receive 60mg of pioglitazone once a day orally for 9 days

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

Patients receive 60mg of pioglitazone once a day orally for 9 days

2

Patients receive Placebo orally once a day for 9 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients receive placebo once a day orally for 9 days

Interventions

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Pioglitazone

Patients receive 60mg of pioglitazone once a day orally for 9 days

Intervention Type DRUG

Placebo

Patients receive placebo once a day orally for 9 days

Intervention Type DRUG

Eligibility Criteria

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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
* Cardiac, renal or respiratory failure
* Previous surgical or transjugular intrahepatic portosystemic shunt
* Insulin-dependent diabetes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gastroenterology and Hepatology, Medical University of Vienna

Principal Investigators

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Arnulf Ferlitsch, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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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. doi: 10.1097/01.ccm.0000178173.27923.eb.

Reference Type BACKGROUND
PMID: 16148476 (View on PubMed)

Other Identifiers

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CIRRPIO

Identifier Type: -

Identifier Source: org_study_id