Danish Carvedilol Study in Portal Hypertension
Information source: Hvidovre University Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis; Portal Hypertension
Intervention: carvedilol or propranolol (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hvidovre University Hospital Official(s) and/or principal investigator(s):
Erik feldager Hansen, MD,Ph.d, Principal Investigator, Affiliation: Unaffiliated
Overall contact:
Lise Hobolth, MD, Phone: +4536326540, Email: lise.hobolth@hvh.regionh.dk
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.
Clinical Details
Official title: Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: If Carvedilol has better efficacy on lowering the portal pressure than propranolol in patients with cirrhosis
Secondary outcome: If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Lise Hobolth, MD, Phone: +4536326540, Email: lise.hobolth@hvh.regionh.dk
Hvidovre Hospital, Hvidovre 2650, Denmark; Recruiting
Lise Hobolth, MD., Phone: +4536326540, Email: lise.hoblth@hvh.regionh.dk
Additional Information
Starting date: September 2003
Last updated: July 11, 2008
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