Cirrhosis of the liver
Conditions
Interventions
Trade Name: Pioglitazone (ACTOS tm)
Product Name: Actos
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Dept. of Clinical Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients (male and female) aged older than 18 years with advanced (Child´s Grade B or C) cirrhosis scheduled for hepatic hemodynamic investigation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of hypertensitivity 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 criteras for hepatic hemodynamic investigation - Cardiac, renal or respiratory failure - previous surgical or transjugular intrahepatic portosystemic shunt - insulin-dependent diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the response to pioglitazone on the hepatic venous pressure gradient and peripheral vascular responsiveness to vasoconstrictors in patients with advanced cirrhosis.;Secondary Objective: To investigate the response to pioglitazone of systemic and pulmonary hemodynamics and markers of oxidative stress in patients with advanced cirrhosis.;Primary end point(s): - HPVG before and after test-meal - Forearm blood flow responses | — |
Countries
Austria
Outcome results
None listed