Bosentan for Mild Pulmonary Vascular Disease in Asd Patients. (BOMPA)
|ClinicalTrials.gov Identifier: NCT01218607|
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : March 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Septal Defects, Atrial||Drug: Bosentan Drug: Placebo||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||BOsentan for Mild Pulmonary Vascular Disease in Asd Patients (the BOMPA Trial): a Double-blind, Randomized Controlled, Pilot Trial|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
|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
- Pulmonary vascular resistance [ Time Frame: 16 weeks ]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 ]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 ]Right ventricular function as assessed by echocardiography.
- Liver function abnormalities [ Time Frame: 4, 8,12 and16 weeks ]An increase in ASAT and/or ALAT equal or more than 3 times the upper limit of normal.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218607
|University Hospitals Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Werner Budts, MD, PhD||University Hospitals Leuven|