Phase 3
Completed N=41
Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
Scleroderma, Systemic · Scleroderma, Diffuse · Scleroderma, Limited · Raynaud Phenomenon
Source: ClinicalTrials.gov NCT01347008 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus — 260.0; 246.3 perfusion units
◆ Published Evidence
Emerging
6citations · ~2 / year
Phosphodiesterase 5 inhibitors (PDE5i) for the treatment of Raynaud's phenomenon.
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.
Linked Publications
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Phosphodiesterase 5 inhibitors (PDE5i) for the treatment of Raynaud's phenomenon.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus |
260.0; 246.3 | — |
| PRIMARY Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus. |
257.7; 220.5 | — |
| SECONDARY Daily Frequency of Raynaud's Phenomenon Attacks |
1.9; 1.7 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01347008) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.