Danish Carvedilol Study in Portal Hypertension

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2009

Interventions

  • 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

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

Clinical Trial Outcome Measures

Primary Measures

  • If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment
    • Time Frame: 3 months

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

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hvidovre University Hospital
  • Provider of Information About this Clinical Study
    • Erik Feldager/ sponsor, Erik Feldager, Hvidovre Hospital
  • Overall Official(s)
    • Erik F Hansen, MD,Ph.d, Principal Investigator,

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