To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation. MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension
Conditions
Interventions
Trade Name: Tracleer
Product Name: Tracleer
Product Code: 66215-101
Pharmaceutical Form: Coated tablet
INN or Proposed INN: BOSENTAN
CAS Number: 147536978
Current Sponsor code: 03602
Other descriptive
Sponsors
ICIN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Patients are not eligible for this study if the following inclusion criteria apply: - Systemic arterial pressure 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation. ;Secondary Objective: Change in: a. changes in six-minute-walk-distance b. change in quality of life score c. change in prevalence of arrhythmias d. changes in congestive heart failure (hospital admission, use of medication for congestive heart failure e. changes in prevalence of protein losing enteropathy f. changes in serum of neurohormones level (NT-pro BNP, endothelin-1) g. changes in cardiac output h changes in arterial oxygen saturation i. changes in number of deaths ;Primary end point(s): change in aerobic capacity. Sample size calculation is based on the primary endpoint change in aerobic capacity (percentage of predicted VO2max). Giardini et al (2008) found a mean improvement in peak V’O2 of 1.9 ml/kg/min (change 9.% ± 5.2%) after treatment with sildenafil in 18 patients with a Fontan circulation (78% total cavo-pulmonary connection).6 Based on a standard deviation of 1.89 we calculated that 32 patients are required to obtain 80% power to detect a difference in mean percentage of peak VO2 2.0 ml/kg/min between the two groups after 12 weeks with a 2 sided a of 0.05. To accommodate for a 10% drop out, the inclusion of at least 40 patients is advised. According to the CONCOR database, the capacity of our study centres meets this criterion | — |
Countries
Netherlands
Outcome results
None listed