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

Primary Purpose

Scleroderma, Systemic, Scleroderma, Diffuse, Scleroderma, Limited

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Sildenafil citrate
Placebo (Sugar pill)
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma, Systemic focused on measuring Sildenafil, Endothelial Progenitor Cells, Laser Doppler Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Systemic Sclerosis Outpatient Clinic, Hospital Sao Paulo, UNIFESP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sildenafil citrate

Sugar pill

Arm Description

Oral Sildenafil citrate, 50mg, b.i.d.

Placebo pill (identical to Sildenafil citrate 50mg), b.i.d.

Outcomes

Primary Outcome Measures

Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus
Finger blood flow of the four medial fingers, measured by laser Doppler imaging and expressed in arbitrary perfusion units (p.u.).
Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus.

Secondary Outcome Measures

Daily Frequency of Raynaud's Phenomenon Attacks
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.

Full Information

First Posted
May 2, 2011
Last Updated
October 12, 2016
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01347008
Brief Title
Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic, Scleroderma, Diffuse, Scleroderma, Limited, Raynaud Phenomenon
Keywords
Sildenafil, Endothelial Progenitor Cells, Laser Doppler Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sildenafil citrate
Arm Type
Active Comparator
Arm Description
Oral Sildenafil citrate, 50mg, b.i.d.
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo pill (identical to Sildenafil citrate 50mg), b.i.d.
Intervention Type
Drug
Intervention Name(s)
Sildenafil citrate
Other Intervention Name(s)
Sildenafil citrate, EMS Sigma Pharma, Ltd, Brazil
Intervention Description
Oral sildenafil citratre, 50mg b.i.d., 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo (Sugar pill)
Other Intervention Name(s)
Placebo
Intervention Description
Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
Primary Outcome Measure Information:
Title
Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus
Description
Finger blood flow of the four medial fingers, measured by laser Doppler imaging and expressed in arbitrary perfusion units (p.u.).
Time Frame
8 weeks
Title
Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Daily Frequency of Raynaud's Phenomenon Attacks
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando V Andrigueti, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Systemic Sclerosis Outpatient Clinic, Hospital Sao Paulo, UNIFESP
City
Sao Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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