Status:
TERMINATED
Effects of Bosentan on Respiratory Mechanics
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 concomitan...
Detailed Description
Endothelins are powerful vasoconstrictor peptides that also play numerous other functions in many different organs. Endothelin-1 (ET-1) is the most abundant and important of this family of peptides in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00679068
Start Date
May 1 2008
End Date
June 1 2013
Last Update
August 20 2015
Active Locations (1)
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1
Respiratory Unit, Fondazione S.Maugeri
Pavia, PV, Italy, 27100