Danish Carvedilol Study in Portal Hypertension (DACAPO)

Hvidovre University Hospital

Status and phase: Completed; Phase 3

Conditions: Portal Hypertension; Cirrhosis

Treatments: Drug: propranolol; Drug: carvedilol

Study type: Interventional

Funder types: Other

Identifiers

NCT00493480

KF-02-049/03

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

carvedilol

Active Comparator group

Treatment:

Drug: carvedilol

propranolol

Active Comparator group

Description:

Cirrhotic patients treated with propranolol

Treatment:

Drug: propranolol