Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
Recruitment status was Recruiting
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.
Drug: Sildenafil citrate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Sildenafil on the Microcirculatory Blood Flow and on the Endothelial Progenitor Cells in Patients With Systemic Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial|
- Digital skin microvascular blood flow by means of Laser Doppler Imaging (LDI). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Number and proliferative capacity of endothelial progenitor cells (EPC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Serum levels of vascular endothelial growth factor (VEGF) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Clinical features of Raynaud's phenomenon and digital ulcers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Raynaud's Condition Score, HAQ and specific VAS scales for Raynaud's phenomenon and disability.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Sildenafil citrate
Oral Sildenafil citrate, 50mg, b.i.d.
Drug: Sildenafil citrate
Oral sildenafil citratre, 50mg b.i.d., 8 weeks
|Placebo Comparator: Sugar pill||
Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
Progressive microangiopathy and endothelial dysfunction are identified in early phases of systemic sclerosis. These alterations may result in progressive reduction of vessel lumen, decreased blood flow, and a state of chronic hypoxia resulting in digital ulcers, digital pitting, and, in more severe cases, gangrene and amputation of the extremities. Few studies aimed to evaluate the effects of Sildenafil on the microcirculatory blood flow in patients with Raynaud's phenomenon secondary to systemic sclerosis (SS). Moreover, no study has evaluated the effect of this drug on the number and function of endothelial progenitor cells in SS patients. The relatively new technique of laser Doppler imaging (LDI) allows an objective measurement of superficial cutaneous microvascular blood flow and constitutes a promising approach in the assessment of the digital microvascular vasoreactivity in response to cold stimulus or in response to treatment in SSc patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347008
|Contact: Fernando V Andrigueti, MD||55 11 firstname.lastname@example.org|
|Systemic Sclerosis Outpatient Clinic, Hospital Sao Paulo, UNIFESP||Recruiting|
|Sao Paulo, SP, Brazil|
|Contact: Fernando V Andrigueti, MD 55 11 55764239 email@example.com|
|Sub-Investigator: Fernando V Andrigueti, MD|