Placebo Controlled Trial of Bosentan in Scleroderma Patients

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the drug Bosentan improves exercise tolerance in scleroderma patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Actelion
• Treatments: Bosentan

Criteria

Inclusion Criteria:

• SSc patients > 18 with NYHA functional Class I/II symptoms, informed consent, and who are willing to participate in the Pulmonary Hypertension Assessment and Recognition of Outcomes in Scleroderma (PHAROS) long term study (Georgetown IRB 04-227)

• Right heart catheterization with

1. Normal Mean Pulmonary Arterial Pressure (PAP) at rest

2. Mean PAP > 30 with exercise

3. Wedge Pressure < 18

• Entry criteria for participating in the exercise echocardiogram study (Georegtown IRB 03-363)

1. Diffusing Capacity (DLCO) <60 with a Forced Vital Capacity (FVC) >60%, or

2. FVC/DLCO > 1.6, or

3. a resting Pulmonary Arterial Systolic Pressure (PASP)> 40mmHg

Exclusion Criteria:

• Established resting pulmonary hypertension

• Congestive heart failure

• Diastolic dysfunction

• Pregnancy

• Inability to adequately walk/exercise

• Severe liver disease