The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers.

Phase 4

Completed

• Conditions: scleroderma; Systemic sclerosis; 10003816

• Registration Number: NL-OMON45095
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

SSc patients
* 18 years or older
* Systemic sclerosis based on the 2013 ACR/EULAR criteria
* Raynaud*s phenomenon (RP)
* A history of digital ulcer disease
* Assessable Pulse Wave Velocity (PWV) measurement at baseline
* Written informed consent;Healthy controls:
* 18 years or older
* Written informed consent

Exclusion Criteria

SSc patients:
* Hypersensitivity to the active substance or to any of the excipients
* Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C
* Baseline values of liver aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT), 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 for example diabetes, dyslipidemia, systemic hypertension, coagulopathy;Healthy controls:
* Comorbidities

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean of right and left carotid-femoral arterial (i.e. aortic) Pulse Wave<br /><br>Velocity (cfPWV)</p><br>