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Danish Carvedilol Study in Portal Hypertension (DACAPO)

Primary Purpose

Cirrhosis, Portal Hypertension

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
carvedilol
propranolol
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

carvedilol

propranolol

Arm Description

Cirrhotic patients treated with propranolol

Outcomes

Primary Outcome Measures

If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment

Secondary Outcome Measures

If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol

Full Information

First Posted
June 27, 2007
Last Updated
August 7, 2009
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00493480
Brief Title
Danish Carvedilol Study in Portal Hypertension
Acronym
DACAPO
Official Title
Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Portal Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
carvedilol
Arm Type
Active Comparator
Arm Title
propranolol
Arm Type
Active Comparator
Arm Description
Cirrhotic patients treated with propranolol
Intervention Type
Drug
Intervention Name(s)
carvedilol
Intervention Description
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
Intervention Name(s)
propranolol
Intervention Description
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
Primary Outcome Measure Information:
Title
If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik F Hansen, MD,Ph.d
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23031335
Citation
Bonefeld K, Hobolth L, Juul A, Moller S. The insulin like growth factor system in cirrhosis. Relation to changes in body composition following adrenoreceptor blockade. Growth Horm IGF Res. 2012 Dec;22(6):212-8. doi: 10.1016/j.ghir.2012.09.001. Epub 2012 Sep 30.
Results Reference
derived
PubMed Identifier
22401315
Citation
Hobolth L, Moller S, Gronbaek H, Roelsgaard K, Bendtsen F, Feldager Hansen E. Carvedilol or propranolol in portal hypertension? A randomized comparison. Scand J Gastroenterol. 2012 Apr;47(4):467-74. doi: 10.3109/00365521.2012.666673. Epub 2012 Mar 9.
Results Reference
derived

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Danish Carvedilol Study in Portal Hypertension

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