Danish Carvedilol Study in Portal Hypertension - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cirrhosis Portal Hypertension	Drug: carvedilol or propranolol	Phase III

MedlinePlus related topics:

Cirrhosis Esophagus Disorders High Blood Pressure Varicose Veins

Drug Information available for:

Propranolol Dexpropranolol Propranolol hydrochloride Carvedilol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

If Carvedilol has better efficacy on lowering the portal pressure than propranolol in patients with cirrhosis [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2003
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Cirrhotic patients treated with carvedilol	Drug: carvedilol or propranolol The patients are randomized to receive either 80 mg of propranolol or 6.25 mg of carvedilol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubled weekly up to a maximum of 360 mg propranolol or 25 mg carvedilol daily.
2: Active Comparator Cirrhotic patients treated with propranolol	Drug: carvedilol or propranolol The patients are randomized to receive either 80 mg of propranolol or 6.25 mg of carvedilol for 12 weeks, to achieve a satisfactory pulse reduction the doses are doubled weekly up to a maximum of 360 mg propranolol or 25 mg carvedilol daily.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493480

Contacts


Contact: Lise Hobolth, MD	+4536326540	lise.hobolth@hvh.regionh.dk

Contact: Erik Feldager Hansen, MD,Ph.D	+4536326301	erik.feldager@hvh.regionh.dk

Locations


Denmark
	Hvidovre Hospital	Recruiting
	Hvidovre, Denmark, 2650
	Contact: Lise Hobolth, MD. +4536326540 lise.hoblth@hvh.regionh.dk

Sponsors and Collaborators

Hvidovre University Hospital

Investigators


Principal Investigator:	Erik feldager Hansen, MD,Ph.d	Unaffiliated

More Information

Responsible Party:	Erik Feldager, Hvidovre Hospital ( Erik Feldager/ sponsor )
Study ID Numbers:	KF-02-049/03
First Received:	June 27, 2007
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00493480
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Study placed in the following topic categories:

Liver Diseases

Esophageal disorder

Fibrosis

Vascular Diseases

Liver Cirrhosis

Hypertension, Portal

Hemorrhage

Portal hypertension

Esophageal varices

Digestive System Diseases

Propranolol

Varicose Veins

Esophageal Diseases

Carvedilol

Hypertension

Additional relevant MeSH terms:

Vasodilator Agents

Neurotransmitter Agents

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Adrenergic alpha-Antagonists

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Pathologic Processes

Therapeutic Uses

Adrenergic beta-Antagonists

Cardiovascular Diseases

Adrenergic Antagonists

Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00493480