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

Non-invasive parameters in the evaluation of portal hypertension in patients with liver cirrhosis and their significance for the evolution of cardial complications.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001132-30-CZ

Enrollment

100

Registered

2011-04-14

Start date

2011-06-07

Completion date

Unknown

Last updated

2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 13.1 Level: LLT Classification code 10009210 Term: Cirr

Interventions

Trade Name: Dilatrend 25 Pharmaceutical Form: Tablet CAS Number: 72956-09-3 Other descriptive name: CARVEDILOL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

Czech Republic

Contacts

Public ContactIV. interní klinika

Všeobecná fakultní nemocnice v Praze

bruha@cesnet.cz00420224962580

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026