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

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ClinicalTrials.gov Identifier: NCT01347008
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Fernando Villela Andrigueti, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE May 2, 2011
First Posted Date  ICMJE May 4, 2011
Results First Submitted Date  ICMJE August 20, 2016
Results First Posted Date  ICMJE December 5, 2016
Last Update Posted Date December 5, 2016
Study Start Date  ICMJE April 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
  • 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.).
  • Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus. [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2011)
Digital skin microvascular blood flow by means of Laser Doppler Imaging (LDI). [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT01347008 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2011)
  • Number and proliferative capacity of endothelial progenitor cells (EPC) [ Time Frame: 8 weeks ]
  • Serum levels of vascular endothelial growth factor (VEGF) [ Time Frame: 8 weeks ]
  • Clinical features of Raynaud's phenomenon and digital ulcers [ Time Frame: 8 weeks ]
    Raynaud's Condition Score, HAQ and specific VAS scales for Raynaud's phenomenon and disability.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Scleroderma, Systemic
  • Scleroderma, Diffuse
  • Scleroderma, Limited
  • Raynaud Phenomenon
Intervention  ICMJE
  • Drug: Sildenafil citrate
    Oral sildenafil citratre, 50mg b.i.d., 8 weeks
    Other Name: Sildenafil citrate, EMS Sigma Pharma, Ltd, Brazil
  • Drug: Placebo (Sugar pill)
    Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
    Other Name: Placebo
Study Arms  ICMJE
  • Active Comparator: Sildenafil citrate
    Oral Sildenafil citrate, 50mg, b.i.d.
    Intervention: Drug: Sildenafil citrate
  • Placebo Comparator: Sugar pill
    Placebo pill (identical to Sildenafil citrate 50mg), b.i.d.
    Intervention: Drug: Placebo (Sugar pill)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2016)
41
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2011)
44
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01347008
Other Study ID Numbers  ICMJE FAPESP 2011/00012-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fernando Villela Andrigueti, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Fernando V Andrigueti, MD Federal University of Sao Paulo
PRS Account Federal University of São Paulo
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP