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Danish Carvedilol Study in Portal Hypertension

Information source: Hvidovre University Hospital
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cirrhosis; Portal Hypertension

Intervention: carvedilol (Drug); 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 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

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.hobolth@hvh.regionh.dk
Additional Information

Starting date: September 2003
Last updated: January 28, 2009

Page last updated: February 12, 2009

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