Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

Early phases of systemic sclerosis is characterized by inflammatory and microvasculature alterations. Sildenafil citrate has been shown to have vasodilatory effects and to enhance vasculogenesis. The purpose of this study is to evaluate the effect of sildenafil citrate on hand blood flow of patients with systemic sclerosis, using Laser Doppler Imaging.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Citric Acid; Sildenafil Citrate; Sodium Citrate

Criteria

Inclusion Criteria:

• Systemic sclerosis according to the classification criteria of the American College of Rheumatology (1980) with no more than 4 years since diagnosis

• Early systemic sclerosis as defined by LeRoy and Medsger (2001)

• 6 or more Raynaud's crisis per week

• Written informed consent provided by the subjects prior to initiating study procedures

Exclusion Criteria:

• Smoking

• Peripheral or central vasculopathy other than Systemic sclerosis

• Uncontrolled Diabetes

• Liver disease

• Pregnant or lactating woman

• Current use of cyclosporin, prostanoids, bosentan or any PDE-5 inhibitors (including current Sildenafil use during randomization)

• History of stroke, myocardial infarction or life threatening cardiac condition within the last 6 months

• History of surgical sympathectomy

• Systolic blood pressure < 85mm Hg

• History of scleroderma renal crisis

• Known hypersensitivity to Sildenafil or any of the excipients

• History of Retinitis Pigmentosa

• Current use of Nitrates