The usefullness of non-invasive parameters in the evaaluation of portal hypertension.

Phase 1

• Conditions: In the prevention of variceal bleeding betablockers are used. The efficacy of betablockers is evaluated by repeated HVPG measurement. The aims: To evaluate the relationship between the polymorphisms of beta-2 adrenergic receptors to the treatment response in patients with portal hypertension treated with carvedilol. Project will be performed as a prospective study on 100 patients with liver cirrhosis and portal hypertension; MedDRA version: 13.1Level: LLTClassification code 10009210Term: Cirrhosis biliarySystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-001132-30-CZ
• Lead Sponsor: Všeobecná fakultní nemocnice v Praze

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-14
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Liver cirrhosis with portal hypertension and esophageal varices
Indication for treatment with betablockers in the prevention of variceal bleeding
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hepatocellular carcinoma
Advanced liver failure (Child-Pugh more than 13 points)
Contraindication to carvedilol:
Decompensated hearth failureNYHA IV
Known sensitivity to carvedilol or vehicules
Astma bronchiale
A-V block 2-3. degree
Severe bradycardie (under 50 beats/min)
Cardiogenic shock
Sick-sinus syndrom
Severe hypotension (systolic BP under 85 mm Hg)
Portosystemic shunt
Portal vein thrombosis
Gravidity or lactation
Age under 18 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the relationship between the polymorphisms of beta-2 adrenergic receptors to the treatment response in patients with portal hypertension treated with carvedilol;Secondary Objective: To evaluate the relationship between noninvasive parameters of hepatic fibrosis and degree of portal hypertension and to evaluate the possibility to replace the invasive measurement of HVPG by use of these parameters;Primary end point(s): treatmen efficacy;Timepoint(s) of evaluation of this end point: 2 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): No secondary endpoints;Timepoint(s) of evaluation of this end point: See E.5.2