Cirrhosis, Portal Hypertension
Conditions
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.
Interventions
DRUGcarvedilol
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.
DRUGpropranolol
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
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol | 3 months |
Countries
Denmark
Outcome results
None listed