We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Danish Carvedilol Study in Portal Hypertension (DACAPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00493480
Recruitment Status : Completed
First Posted : June 28, 2007
Last Update Posted : August 10, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Cirrhosis Portal Hypertension Drug: carvedilol Drug: propranolol Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices
Study Start Date : September 2003
Primary Completion Date : August 2009
Study Completion Date : August 2009


Arms and Interventions

Arm Intervention/treatment
Active Comparator: carvedilol 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.
Active Comparator: propranolol
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


Outcome Measures

Primary Outcome Measures :
  1. If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erik Feldager/ sponsor, Erik Feldager, Hvidovre Hospital
ClinicalTrials.gov Identifier: NCT00493480     History of Changes
Other Study ID Numbers: KF-02-049/03
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: August 10, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Propranolol
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists