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 pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome).
Conditions
Interventions
Trade Name: Tracleer
Product Name: Tracleer
Pharmaceutical Form: Tablet
Other descriptive name: Bosentan monohydrat
Trade Name: VIAGRA
Product Name: Viagra
Pharmaceutical Form: Tablet
Other descripti
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eisenmenger Syndrome Al least 18 years old Negative pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Raised liver enzymes to more than 3 times normal values. Recently stroke or myocardial infarction(3 months) Allergy to medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We would like to examine the effect of treating patients with Eisenmengers Syndrome with a combination of Bosentan and Sildenafil.;Secondary Objective: Secondary end points is change in saturation, NYHA class, cardiac output (cardiac catheterization and inocor measurement), pulmonary vascular resistence (cardiac catheterization) shunt ratio (MRI), strain of right ventricle (BNP and echocardiography) and serum erythropoitin.;Primary end point(s): The primary end point is change in physical performance measured with six minutes walking test. | — |
Countries
Denmark
Outcome results
None listed