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

NCT02480335 | Completed Phase 4

• 1 other identifier: NL49919.042.14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scleroderma, Systemic

Outcome Measures

Primary Outcomes (1)

• Mean of right and left carotid-femoral arterial (i.e. aortic) Pulse Wave Velocity (cfPWV)

  assessed with Sphygmocor

  3 months

Secondary Outcomes (31)

• Mean of right and left carotid-femoral arterial (i.e. aortic) Pulse Wave Velocity (cfPWV)

  12 months

• Right carotid-brachial arterial PWV (cbPWV)

  3 and 12 months

• Left carotid-brachial arterial PWV (cbPWV)

  3 and 12 months

• Right carotid-radial arterial PWV (crPWV)

  3 and 12 months

• Left carotid-radial arterial PWV (crPWV)

  3 and 12 months

Study Arms (2)

Usual care and bosentan

EXPERIMENTAL

Usual care and also treatment with bosentan.

Drug: bosentan

Usual care

NO INTERVENTION

Usual care only.

Interventions

bosentan DRUG

62.5 mg oral twice daily for 4 weeks, then 125 mg oral twice daily.

Also known as: tracleer

Usual care and bosentan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Actelion: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andries J Smit, MDPhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Douwe J. Mulder

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 24, 2015
• Study Start: June 26, 2015
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

NL (1)