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CompletedNCT01347008Updated Dec 5, 2016Results posted

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

A Phase 3 interventional study of Sildenafil citrate and Placebo (Sugar pill) in Scleroderma, Systemic, Scleroderma, Diffuse and Scleroderma, Limited, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-05.

Sponsored by Federal University of São Paulo · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Scleroderma, Systemic
  • Scleroderma, Diffuse
  • Scleroderma, Limited
  • Raynaud Phenomenon

Keywords

  • Sildenafil
  • Endothelial Progenitor Cells
  • Laser Doppler Imaging
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In context

Raynaud Disease

83 studies on the registry are indexed under Raynaud Disease; 8 are open to participants now.

This study's enrollment of 41 is above the median of 30 across 71 interventional studies indexed under Raynaud Disease.

Browse Raynaud Disease studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
41 participants (actual)

Study arms

  • Active comparator
    Sildenafil citrate

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

    Drug: Sildenafil citrate

  • Placebo comparator
    Sugar pill

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

    Drug: Placebo (Sugar pill)

Interventions

  • DrugSildenafil citrate

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

    Also known as: Sildenafil citrate, EMS Sigma Pharma, Ltd, Brazil

  • DrugPlacebo (Sugar pill)

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

    Also known as: Placebo

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What researchers measure

Primary outcomes

  1. 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.).

    Time frame: 8 weeks

  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

    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

07

Results

Posted Dec 5, 2016
Limitations and caveats
Small numbers of subjects analyzed; blood flow differences due to outside temperature variations

Participant flow

Patients recruited at the Outpatient Clinic of The Federal University of Sao Paulo, between August 2011 and November 2012

Participant flow — Overall Study
MilestoneSildenafil CitrateSugar Pill
Started2120
Completed2120
Not completed00

Outcome measures

PrimaryDigital 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.).

Time frame:
8 weeks
Reported as:
Mean · perfusion units
Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus
perfusion unitsSildenafil CitrateSugar Pill
Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus260.0 ± 108.0246.3 ± 122.6
PrimaryDigital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus.
Time frame:
8 weeks
Reported as:
Mean · perfusion units
Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus.
perfusion unitsSildenafil CitrateSugar Pill
Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus.257.7 ± 123.3220.5 ± 119.9
SecondaryDaily 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.

Time frame:
8 weeks
Reported as:
Mean · number of attacks per day
Daily Frequency of Raynaud's Phenomenon Attacks
number of attacks per daySildenafil CitrateSugar Pill
Daily Frequency of Raynaud's Phenomenon Attacks1.9 ± 2.41.7 ± 2.2

Adverse events

Collected over 10 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sildenafil Citrate—0/21 (0%)7/21 (33.3%)
Sugar Pill—0/20 (0%)1/20 (5%)
Most frequent other events
Most frequent other events
EventSildenafil CitrateSugar Pill
HeadacheNervous system disorders7/211/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)Sildenafil CitrateSugar PillTotal
Mean47.2 ± 10.941.6 ± 13.344.5 ± 12.3
Sex: Female, Male
Sex: Female, Male(Participants)Sildenafil CitrateSugar PillTotal
Female212041
Male000
Region of Enrollment
Region of Enrollment(participants)Sildenafil CitrateSugar PillTotal
Brazil212041
Digital skin microvascular blood flow measured by Laser Doppler Imaging (LDI) before cold stimulus
Digital skin microvascular blood flow measured by Laser Doppler Imaging (LDI) before cold stimulus(perfusion units)Sildenafil CitrateSugar PillTotal
Mean213.1 ± 87.9241.9 ± 104.4234.6 ± 105.8
Digital skin microvascular blood flow measured by Laser Doppler Imaging (LDI) after cold stimulus.
Digital skin microvascular blood flow measured by Laser Doppler Imaging (LDI) after cold stimulus.(perfusion units)Sildenafil CitrateSugar PillTotal
Mean178.8 ± 92.4218.6 ± 98.9200.2 ± 96.1
Daily frequency of Raynuad's Phenomenon attacks
Daily frequency of Raynuad's Phenomenon attacks(number of attacks per day)Sildenafil CitrateSugar PillTotal
Mean2.3 ± 2.51.9 ± 2.02.1 ± 2.3
08

Study locations

1 site
  • Systemic Sclerosis Outpatient Clinic, Hospital Sao Paulo, UNIFESP
    Sao Paulo, SP, Brazil
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01347008
Lead sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Fernando Villela Andrigueti (MD, Federal University of São Paulo) — Principal investigator
First posted
May 4, 2011
Start date
Apr 2011
Primary completion
Jan 2013
Completion
Jan 2013
Results posted
Dec 5, 2016
Last update
Dec 5, 2016

Study contacts

Fernando V Andrigueti, MD
principal investigator · Federal University of São Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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