Danish Carvedilol Study in Portal Hypertension

Phase 3

Completed

• Conditions: Cirrhosis; Portal Hypertension
• Interventions: Drug: carvedilol; Drug: propranolol

• Registration Number: NCT00493480
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

Patients with large esophageal varices who have not yet experienced bleeding, are normally treated with propranolol, a beta blocking agent that reduces the portal pressure and thereby diminish the risk of bleeding. 20-40% of the patients do not respond to this treatment or have to discontinue the treatment because of side effects. The aim of this study is to evaluate if carvedilol (a combined alfa -beta blocker) has better efficacy and safety than propranolol in lowering the portal pressure in patients with cirrhosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-27
• Study First Posted: 2007-06-28
• Status Verified: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2009-08-07
• Last Update Posted: 2009-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Cirrhosis
• HVPG > 12 mmHg

Exclusion Criteria

• Respiratory disease that contradict endoscopy
• Hepatic encephalopathy
• Hepatorenal syndrome
• COPD or Asthma
• Treatment with vasoactive drugs within 1 week of inclusion
• Heart disease that contradict treatment with beta-blocking agents
• IDDM
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carvedilol	carvedilol	-
propranolol	propranolol	Cirrhotic patients treated with propranolol

Primary Outcome Measures

Name	Time	Method
If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment	3 months

Secondary Outcome Measures

Name	Time	Method
If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol	3 months

Trial Locations

Locations (1)

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark