aerobic capacity (peak V’O2) quality of life prevalence of arrhythmias prevalence of protein losing enteropathy
Conditions
Interventions
One group receives a 125 mg tablet of Bosentan twice daily for 6 months. The other group does not receive study medication for the first 3 months, followed by treatment with study medication for 6 mon
Sponsors
none
Eligibility
Inclusion criteria
Inclusion criteria: 1. All adult Fontan patients are potentially eligible for this study.
Exclusion criteria
Exclusion criteria: - Patients are not eligible for this study if the following inclusion criteria apply: 1. Systemic arterial pressure three times limiting value 7. Simultaneous use of cyclosporine A 8. Desire to have children within the study period or women who do not use reliable contraceptive methods 9. Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To determine the effect of the following parameters. - changes in six-minute-walk-distance - changes in quality of life score - changes in prevalence of arrhythmias - changes in congestive heart failure (hospital admission, use of medication for congestive heartfailure) - changes in prevalence of protein losing enteropathy - changes in serum neurohormone level (NT-pro BNP, endothelin-1, albumin) - changes in cardiac output - changes in arterial oxygen saturation - changes in number of deaths | — |
Contacts
Public ContactB.J.M. Mulder
Academic Medical Centre (AMC) Department of cardiology Room F3 – 115
Outcome results
None listed