Danish Carvedilol Study in Portal Hypertension (DACAPO)

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00493480
First received: June 27, 2007
Last updated: August 7, 2009
Last verified: August 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:


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
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

  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
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, see Learn About Clinical Studies.

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 by Hvidovre University Hospital

Additional 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
Study First Received: June 27, 2007
Last Updated: August 7, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Liver Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Propranolol
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on September 14, 2014