The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic Sclerosis

• Status: Completed
• Trial end date: 2018-07-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to investigate whether bosentan added to usual care improves arterial stiffness after 3 months as measured as the pulse wave velocity (PWV) of the medium and large arteries corrected for blood pressure changes in patients with systemic sclerosis (SSc) with digital ulcers (DU). Patients will be randomized into a group with usual care and bosentan (n=10) or usual care only (n=10). PWV will be assessed at baseline, 3 months and 12 months.

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

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Actelion
• Treatments: Bosentan

Criteria

Inclusion Criteria:

• 18 years or older

• Systemic sclerosis based on the 2013 American College of Rheumatology/European League Against Rheumatism criteria

• Raynaud's phenomenon

• A history of digital ulcer disease

• Assessable Pulse Wave Velocity measurement at baseline

• Written informed consent

Exclusion Criteria:

• Hypersensitivity to the active substance or to any of the excipients

• Systolic blood pressure lower than 85 mmHg

• Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C

• Baseline values of liver aminotransferases, i.e., aspartate aminotransferases and/or alanine aminotransferases, greater than 3 times the upper limit of normal

• Concomitant use of cyclosporine A

• Pregnancy

• Women of child-bearing potential who are not using reliable methods of contraception

• Significant peripheral vascular disease as the sole consequence of atherosclerotic disease due to conventional vascular risk factors and coagulopathy