The role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patients
- Conditions
- To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation.MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
- Registration Number
- EUCTR2008-004533-21-NL
- Lead Sponsor
- ICI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
All adult Fontan patients are potentially eligible for this study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients are not eligible for this study if the following inclusion criteria apply:
- Systemic arterial pressure < 85 mmHg
- Incapable of giving informed consent
- Hypersensitivity to bosentan or any of its help substances
- Current treatment with bosentan or treatment for pulmonary arterial hypertension
- Moderate to severe liver disease: Child-Pugh class B or C
- Raised plasma transaminases level > three times limiting value.
- Simultaneous use of cyclosporine A
- Pregnant or nursing women (a pregnancy test is offered to every female patient within the fertile age)
- Desire to have children within the study period or women who do not use reliable contraceptive methods
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method