Bosentan for mild pulmonary vascular disease in Asd patients (the BOMPA trial): A double-blind, randomized controlled, pilot trial

摘要

Using bicycle stress echocardiography, pulmonary vascular resistance can be estimated by linear regression analysis of pressure-flow plots. Previously, we have shown that patients who underwent atrial septal defect (ASD) closure at older age (>34 years of age) - although having normal pulmonary artery pressures (PAP) at rest - have an increased dynamic pulmonary vascular resistance (dPVR) as assessed using bicycle stress echocardiography [1]. Increased dPVR seems to be related with exercise intolerance and persistence of tricuspid valve regurgitation (TR) after ASD closure. Both increased dPVR and persistent TR may lead to future complications, such as atrial fibrillation. We hypothesized that disease targeting therapy, such as endothelin receptor antagonists, decreases dPVR in patients who underwent late ASD closure. The purpose of this pilot trial (ClinicalTrials.gov NCT 01218607) was to evaluate the effect of bosentan on dPVR. Ten patients who underwent ASD closure (2 surgical, 8 percutaneous) after the age of 34 years at least six months before study enrolment were included in the study (inclusion from January 2011 to September 2012).