Status:
COMPLETED
Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Eisenmenger Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial.
Detailed Description
Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmo...
Eligibility Criteria
Inclusion
- Eisenmenger syndrome
- Negative pregnancy test
Exclusion
- Elevated liver enzymes to more than 3´times normal value
- Hypotension (SBP \< 90 mmhg).
- Mandatory treatment with nitrates
- Myocardial infarction within 3 months
- Stroke within 3 months
- Known allergy to Bosentan or Sildenafil
- inherited degenerative diseases in retina
- Breast feeding
- Suspicion of risc of noncompliance.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00303004
Start Date
March 1 2006
End Date
January 1 2008
Last Update
January 24 2008
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100