Danish Carvedilol Study in Portal Hypertension
DACAPO
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2003
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 27, 2007
CompletedFirst Posted
Study publicly available on registry
June 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedAugust 10, 2009
August 1, 2009
5.9 years
June 27, 2007
August 7, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment
3 months
Secondary Outcomes (1)
If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol
3 months
Study Arms (2)
carvedilol
ACTIVE COMPARATORpropranolol
ACTIVE COMPARATORCirrhotic patients treated with propranolol
Interventions
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.
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 Criteria
You may qualify if:
- Cirrhosis
- HVPG \> 12 mmHg
You may not qualify if:
- Respiratory disease that contradict endoscopy
- Hepatic encephalopathy
- Hepatorenal syndrome
- COPD or Asthma
- Heart disease that contradict treatment with beta-blocking agents
- IDDM
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hvidovre Hospital
Hvidovre, 2650, Denmark
Related Publications (2)
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.
PMID: 23031335DERIVEDHobolth 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.
PMID: 22401315DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erik F Hansen, MD,Ph.d
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 27, 2007
First Posted
June 28, 2007
Study Start
September 1, 2003
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 10, 2009
Record last verified: 2009-08