The role of Bosentan in fontan patients: improvement of aerobic capacity.
- Conditions
- aerobic capacity (peak V’O2)quality of life prevalence of arrhythmiasprevalence of protein losing enteropathy
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. All adult Fontan patients are potentially eligible for this study.
Exclusion Criteria
- Patients are not eligible for this study if the following inclusion criteria apply:
1. Systemic arterial pressure < 85 mmHg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to determine changes in aerobic capacity (peak V’O2) in adult patients with a Fontan circulation before and after treatment with the bosentan and compared to non-treated patients.
- Secondary Outcome Measures
Name Time Method To determine the effect of the following parameters.<br /><br>- changes in six-minute-walk-distance<br /><br>- changes in quality of life score<br /><br>- changes in prevalence of arrhythmias<br /><br>- changes in congestive heart failure <br />(hospital admission, use of medication for congestive heartfailure) <br /> <br>- changes in prevalence of protein losing enteropathy<br /><br>- changes in serum neurohormone level (NT-pro BNP, endothelin-1, albumin)<br /><br>- changes in cardiac output<br /><br>- changes in arterial oxygen saturation <br /><br>- changes in number of deaths<br>