Bosentan for Mild Pulmonary Vascular Disease in Asd Patients. (BOMPA)
Volume overload due to left-to-right shunting in patients with atrial septal defect type secundum causes pulmonary vascular disease over a long period of time. Pulmonary vascular resistance can be assessed non-invasively using bicycle stress echocardiography. By measuring cardiac output and pulmonary artery pressures at different stages of exercise, a pressure-output plot can be obtained. The slope of the pressure-output plot reflects pulmonary vascular resistance. In patients undergoing ASD repair after the age of 40 years, pulmonary vascular resistance was higher when compared to age-matched controls, indicating the presence of mild pulmonary vascular disease. Bosentan has been shown to decrease pulmonary vascular resistance.
The investigators hypothesize that in patients with an ASD type secundum, who underwent ASD repair after the age of 40 years, administration of bosentan decreases pulmonary vascular resistance as assessed by bicycle stress echocardiography.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||BOsentan for Mild Pulmonary Vascular Disease in Asd Patients (the BOMPA Trial): a Double-blind, Randomized Controlled, Pilot Trial|
- Pulmonary vascular resistance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Pulmonary vascular resistance can be measured using bicycle stress echocardiography by estimating the slope of a pressure-flow plot using linear regression analysis.
- Peak oxygen consumption [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The highest oxygen uptake available by bicycle ergometry despite further work rate increases and effort by the subject.
- Right ventricular function [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Right ventricular function as assessed by echocardiography.
- Liver function abnormalities [ Time Frame: 4, 8,12 and16 weeks ] [ Designated as safety issue: Yes ]An increase in ASAT and/or ALAT equal or more than 3 times the upper limit of normal.
|Study Start Date:||October 2010|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
Placebo will be taken twice daily for 16 weeks
|Active Comparator: Active||
Treatment will be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily for 12 weeks.
Other Name: Bosentan = Tracleer
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|University Hospitals Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Werner Budts, MD, PhD||University Hospitals Leuven|