Bosentan and Sildenfil for patients with Eisenmenger syndrome
- Conditions
- 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).
- Registration Number
- EUCTR2006-000021-57-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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
Raised liver enzymes to more than 3 times normal values.
Recently stroke or myocardial infarction(3 months)
Allergy to medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method