Danish Carvedilol Study in Portal Hypertension - Full Text View

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

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 Drug: propranolol	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Esophagus Disorders High Blood Pressure Varicose Veins

Drug Information available for: Carvedilol Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment [ Time Frame: 3 months ] [ 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: 3 months ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
carvedilol: Active Comparator	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: Active Comparator Cirrhotic patients treated with propranolol	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

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

Locations

Denmark
Hvidovre Hospital
Hvidovre, Denmark, 2650

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

Principal Investigator:

Erik F Hansen, MD,Ph.d

More Information

No publications provided

Responsible Party:	Erik Feldager, Hvidovre Hospital ( Erik Feldager/ sponsor )
Study ID Numbers:	KF-02-049/03
Study First Received:	June 27, 2007
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00493480 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Fibrosis
Physiological Effects of Drugs
Vascular Diseases
Adrenergic alpha-Antagonists
Hypertension, Portal
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Propranolol
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension
Carvedilol

ClinicalTrials.gov processed this record on March 18, 2010