Danish Carvedilol Study in Portal Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2009-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Cirrhosis Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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carvedilol

Group Type ACTIVE_COMPARATOR

carvedilol

Intervention Type 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

Cirrhotic patients treated with propranolol

Group Type ACTIVE_COMPARATOR

propranolol

Intervention Type 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

Interventions

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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.

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No