Effects of Bosentan on Respiratory Mechanics

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Bosentan has been largely used in the treatment of pulmonary hypertension (PH). It can improve exercise capacity, lower Borg dyspnoea score nad these effects are usually associated with the concomitant improvement in cardiopulmonary haemodynamics.

No physiological study has so far verified the hypothesis that Bosentan may laso have an effect on the "respiratory side" of the cadio-pulmonary system (i.e. on pulmonary mechanics and work of breathing)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi; IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Treatments: Bosentan

Criteria

Inclusion Criteria:

• Adult patients with World Health Organization (WHO) functional class II-III.

• A systemic pulse oximetry (SpO2) between 70% and 90% at rest with room air and a baseline 6-minute walk distance between 150 and 450 m were required for inclusion.

• PAH confirmed by cardiac catheterization as mean pulmonary arterial pressure greater or equal to25 mm Hg, pulmonary capillary wedge pressure lower 15 mm Hg,

Exclusion Criteria:

• Patients were excluded if they had patent ductus arteriosus (for hemodynamic assessment difficulties)

• complex congenital heart defect

• left ventricular dysfunction (left ventricular ejection fraction lower 40%)

• restrictive lung disease (total lung capacity lower 70% predicted)

• obstructive lung disease (forced expiratory volume in 1 second [FEV1] lower 70% predicted

• with FEV1/forced vital capacity lower 60%)

• or previously diagnosed coronary artery disease.