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OpenTrials
Completed

NCT Number: NCT00493480

Danish Carvedilol Study in Portal Hypertension

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.

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Key information

Conditions

Cirrhosis Digestive System Diseases Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carvedilol

Drug

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

Drug

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

Primary outcomes

  1. If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment

    Time frame: 3 months

Secondary outcomes

  1. If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Acronym: DACAPO

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Jun 28, 2007
Registry last updated
Aug 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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