Danish Carvedilol Study in Portal Hypertension

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment
  • Time Frame: 3 months
    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: 3 months
    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 Investigator: Hvidovre University Hospital Other

Overall Clinical Trial Officials and Contacts

Erik F Hansen, MD,Ph.d Principal Investigator   

Information obtained from ClinicalTrials.gov on February 12, 2012

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