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

NCT ID: NCT01347008

Last Updated: 2016-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Limited Raynaud Phenomenon

Keywords

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Sildenafil Endothelial Progenitor Cells Laser Doppler Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sildenafil citrate

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

Group Type ACTIVE_COMPARATOR

Sildenafil citrate

Intervention Type DRUG

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

Sugar pill

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

Group Type PLACEBO_COMPARATOR

Placebo (Sugar pill)

Intervention Type DRUG

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

Interventions

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Sildenafil citrate

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

Intervention Type DRUG

Placebo (Sugar pill)

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

Intervention Type DRUG

Other Intervention Names

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Sildenafil citrate, EMS Sigma Pharma, Ltd, Brazil Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Fernando Villela Andrigueti

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fernando V Andrigueti, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Systemic Sclerosis Outpatient Clinic, Hospital Sao Paulo, UNIFESP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Maltez N, Maxwell LJ, Rirash F, Tanjong Ghogomu E, Harding SE, Tingey PC, Wells GA, Tugwell P, Pope J. Phosphodiesterase 5 inhibitors (PDE5i) for the treatment of Raynaud's phenomenon. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD014089. doi: 10.1002/14651858.CD014089.

Reference Type DERIVED
PMID: 37929840 (View on PubMed)

Other Identifiers

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FAPESP 2011/00012-3

Identifier Type: -

Identifier Source: org_study_id