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

NCT01347008 | Completed Phase 3 Results

• 1 other identifier: FAPESP 2011/00012-3
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Limited; Raynaud Phenomenon

Keywords

Sildenafil; Endothelial Progenitor Cells; Laser Doppler Imaging

Outcome Measures

Primary Outcomes (2)

• 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.).

  8 weeks

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

  8 weeks

Secondary Outcomes (1)

• Daily Frequency of Raynaud's Phenomenon Attacks

  8 weeks

Study Arms (2)

Sildenafil citrate

ACTIVE COMPARATOR

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

Drug: Sildenafil citrate

Sugar pill

PLACEBO COMPARATOR

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

Drug: Placebo (Sugar pill)

Interventions

Sildenafil citrate DRUG

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

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

Sildenafil citrate

Placebo (Sugar pill) DRUG

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

Also known as: Placebo

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• or more Raynaud's crisis per week
• Written informed consent provided by the subjects prior to initiating study procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Systemic Sclerosis Outpatient Clinic, Hospital Sao Paulo, UNIFESP

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 37929840 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Limited; Raynaud Disease

Interventions

Sildenafil Citrate; Long-Term Synaptic Depression; Sugars

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Carbohydrates

Limitations and Caveats

Small numbers of subjects analyzed; blood flow differences due to outside temperature variations

Results Point of Contact

• Title: Fernando Villela Andrigueti, MD
• Organization: Federal University of Sao Paulo

fernando.andrigueti@usp.br

+55 11 55764239

Study Officials

• Fernando V Andrigueti, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: May 4, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 5, 2016
• Results First Posted: December 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)