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NCT Number: NCT01347008

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

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.

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Key information

Conditions

Scleroderma, Systemic Cardiovascular Diseases Connective Tissue Diseases Embolism and Thrombosis Livedoid Vasculopathy Peripheral Vascular Diseases Raynaud Disease Raynaud Phenomenon Scleroderma, Diffuse Scleroderma, Limited Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Systemic Sclerosis Outpatient Clinic, Hospital Sao Paulo, UNIFESP

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sildenafil citrate

Drug

Oral sildenafil citratre, 50mg b.i.d., 8 weeks

Other names: Sildenafil citrate, EMS Sigma Pharma, Ltd, Brazil

Placebo (sugar pill)

Drug

Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks

Other names: Placebo

Primary outcomes

  1. Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus

    Time frame: 8 weeks

    Finger blood flow of the four medial fingers, measured by laser Doppler imaging and expressed in arbitrary perfusion units (p.u.).

  2. Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus.

    Time frame: 8 weeks

Secondary outcomes

  1. Daily Frequency of Raynaud's Phenomenon Attacks

    Time frame: 8 weeks

    Daily frequency of RP attacks as self registered in a 1-week diary. Any episode of pallor or cyanosis of the hand/fingers was considered as a RP attack, and patients were supposed to register the daily amount of such episodes on a 1-week diary, previously to the medical visit.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 4, 2011
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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