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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02480335
Date of registration:	15/06/2015
Prospective Registration:	Yes
Primary sponsor:	University Medical Center Groningen
Public title:	The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic Sclerosis CEASESTIFF
Scientific title:	The Clinical Efficacy And Subclinical Effects on Arterial STIFFNESS of Bosentan Therapy Added to Usual Care in Patients With Systemic Sclerosis With Digital Ulcers
Date of first enrolment:	June 26, 2015
Target sample size:	20
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02480335
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
Netherlands

Contacts

Name:	Andries J Smit, MDPhD
Address:
Telephone:
Email:
Affiliation:	University Medical Center Groningen

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Scleroderma, Systemic

Intervention(s)

Drug: bosentan

Primary Outcome(s)

Mean of right and left carotid-femoral arterial (i.e. aortic) Pulse Wave Velocity (cfPWV) [Time Frame: 3 months]

Secondary Outcome(s)

Microangiopathy Evolution Score (MES) [Time Frame: 3 and 12 months]

Blood pressure of the brachial artery [Time Frame: 3 and 12 months]

Mean capillary density of 8 fingers (dig 2-5) [Time Frame: 3 and 12 months]

Capillaroscopic Skin Ulcer Risk Index (CSURI) [Time Frame: 3 and 12 months]

Left carotid-radial arterial PWV (crPWV) [Time Frame: 3 and 12 months]

Local PWV of the right radial artery (rPWV) [Time Frame: 3 and 12 months]

Mean giant capillaries of 8 fingers (dig 2-5) [Time Frame: 3 and 12 months]

Mean widened capillaries of 8 fingers (dig 2-5) [Time Frame: 3 and 12 months]

Right carotid-radial arterial PWV (crPWV) [Time Frame: 3 and 12 months]

Blood flow in the hands in ROI 2: distal of the metacarpal joints and proximal of the PIP joint [Time Frame: 3 and 12 months]

Serum levels of matrix metalloproteinase 3 [Time Frame: 3 and 12 months]

Short Form (36) [Time Frame: 3 and 12 months]

Blood flow in the hands in ROI 3: the hand proximal of the metacarpal joints [Time Frame: 3 and 12 months]

Mean loop width of 8 fingers (dig 2-5) [Time Frame: 3 and 12 months]

Left carotid-brachial arterial PWV (cbPWV) [Time Frame: 3 and 12 months]

Serum levels of tissue inhibitors of metalloproteinases (TIMP) [Time Frame: 3 and 12 months]

Local PWV of the left brachial artery (bPWV) [Time Frame: 3 and 12 months]

Local PWV of the right brachial artery (bPWV) [Time Frame: 3 and 12 months]

Modified Rodnan Skin Score (mRSS) [Time Frame: 3 and 12 months]

Skin Autofluorescence [Time Frame: 3 and 12 months]

Time to healing of digital ulcers [Time Frame: 3 and 12 months]

Local PWV of the left radial artery (rPWV) [Time Frame: 3 and 12 months]

Mean of right and left carotid-femoral arterial (i.e. aortic) Pulse Wave Velocity (cfPWV) [Time Frame: 12 months]

Plasma N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) [Time Frame: 3 and 12 months]

Right carotid-brachial arterial PWV (cbPWV) [Time Frame: 3 and 12 months]

Urine albumin/creatinine ratio (ACR) [Time Frame: 3 and 12 months]

Blood flow in the hands in region of interest (ROI) 1: distal of the proximal interphalangeal (PIP) joint of the 3 middle fingers [Time Frame: 3 and 12 months]

Number of new digital ulcers [Time Frame: 3 and 12 months]

Prognostic Index for Digital Lesions (PILD) [Time Frame: 3 and 12 months]

Scleroderma Health Assessment Questionnaire (SHAQ) [Time Frame: 3 and 12 months]

Serum levels of matrix metalloproteinases 9 [Time Frame: 3 and 12 months]

Secondary ID(s)

NL49919.042.14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Actelion

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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