Danish Carvedilol Study in Portal Hypertension
Information source: Hvidovre University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis; Portal Hypertension
Intervention: carvedilol (Drug); propranolol (Drug)
Phase: Phase 3
Sponsored by: Hvidovre University Hospital
Official(s) and/or principal investigator(s):
Erik F Hansen, MD,Ph.d, Principal Investigator
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.
Official title: Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment
Secondary outcome: If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol
Minimum age: 18 Years.
Maximum age: 70 Years.
- HVPG > 12 mmHg
- 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
Locations and Contacts
Hvidovre Hospital, Hvidovre 2650, Denmark
Starting date: September 2003
Last updated: August 7, 2009