Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Bosentan; Sildenafil Citrate

Criteria

Inclusion Criteria:

• Eisenmenger syndrome

• Negative pregnancy test

Exclusion Criteria:

• 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.