Official Title: “Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: carvedilol or propranolol
  • The patients are randomized to receive either 80 mg of propranolol or 6.25 mg of carvedilol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubled weekly up to a maximum of 360 mg propranolol or 25 mg carvedilol daily.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Cirrhotic patients treated with carvedilol
• Active Comparator: 2
  • Cirrhotic patients treated with propranolol

Primary Measures

• If Carvedilol has better efficacy on lowering the portal pressure than propranolol in patients with cirrhosis
  • Time Frame: 2009
    Safety Issue?: No

Secondary Measures

• If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol
  • Time Frame: 2009
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hvidovre University Hospital

Overall Clinical Trial Officials and Contacts

Erik feldager Hansen, MD,Ph.d Principal Investigator Unaffiliated  

Overall Contact: Lise Hobolth, MD +4536326540 lise.hobolth@hvh.regionh.dk

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00493480

Study ID Number: KF-02-049/03

ClinicalTrials.gov Identifier: NCT00493480

Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics