Danish Carvedilol Study in Portal Hypertension

Cirrhosis Clinical Trial

— DACAPO  

Official title:

Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493480
• Other study ID #: KF-02-049/03
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2007
• Last updated: August 7, 2009
• Start date: September 2003
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis
• Hypertension
• Hypertension, Portal
• Portal Hypertension

Intervention

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.
• 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

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment		3 months	No
Secondary	If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol		3 months	No