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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01347008
• Date of registration: 02/05/2011
• Prospective Registration: No
• Primary sponsor: Federal University of São Paulo
• Public title: Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
• Scientific 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
• Date of first enrolment: April 2011
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01347008
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Brazil

Contacts

• Name: Fernando V Andrigueti, MD
• Affiliation: Federal University of Sao Paulo

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Raynaud Phenomenon

Scleroderma, Systemic

Scleroderma, Limited

Scleroderma, Diffuse

Intervention(s)

Drug: Placebo (Sugar pill)

Drug: Sildenafil citrate

Primary Outcome(s)

Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus. [Time Frame: 8 weeks]

Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus [Time Frame: 8 weeks]

Secondary Outcome(s)

Daily Frequency of Raynaud's Phenomenon Attacks [Time Frame: 8 weeks]

Secondary ID(s)

FAPESP 2011/00012-3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fundação de Amparo à Pesquisa do Estado de São Paulo

Results

• Results available: Yes
• Date Posted: 05/12/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01347008