hepatic cirrhosis MedDRA version: 9.1 Level: LLT Classification code 10019641 Term: Hepatic cirrhosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: histologic diagnosis of hepatic cirrhosis; hepatic cirrhosis with endoscopic signs of portal hypertension; age > 18 years; informed consent; chronic liver disease with ultrasound signs of portal hypertension; patients in current treatment with propranolol; naïve patients with medical prescription to propranolol 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: Contraindication to beta blockers; contraindication to contrast agent Sonovue; thrombosis of splancnic circulation; treatment with others beta blocker; pregnant or breastfeeding women;hepatocellular carcinoma;liver metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of hemodynamic effects of non selective beta blocker by Doppler hepatic vein and with ultrasound contrast agent;Secondary Objective: Prevention of the development of varices in patients with hepatic cirrhosis;Primary end point(s): To assess the flow pattern in hepatic vein and the transit times of Sonovue in hepatic circulation before and after oral admistration of propranolol | — |
Countries
Italy