Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Limited Raynaud Phenomenon |
Drug: Sildenafil citrate Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
- Digital skin microvascular blood flow by means of Laser Doppler Imaging (LDI). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Number and proliferative capacity of endothelial progenitor cells (EPC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Serum levels of vascular endothelial growth factor (VEGF) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Clinical features of Raynaud's phenomenon and digital ulcers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Raynaud's Condition Score, HAQ and specific VAS scales for Raynaud's phenomenon and disability.
| Estimated Enrollment: | 44 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sildenafil citrate
Oral Sildenafil citrate, 50mg, b.i.d.
|
Drug: Sildenafil citrate
Oral sildenafil citratre, 50mg b.i.d., 8 weeks
|
| Placebo Comparator: Sugar pill |
Drug: Placebo
Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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:
- 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
Contacts and Locations| Contact: Fernando V Andrigueti, MD | 55 11 55764239 | fe_villela@yahoo.com.br |
| Brazil | |
| Systemic Sclerosis Outpatient Clinic, Hospital Sao Paulo, UNIFESP | Recruiting |
| Sao Paulo, SP, Brazil | |
| Contact: Fernando V Andrigueti, MD 55 11 55764239 fe_villela@yahoo.com.br | |
| Sub-Investigator: Fernando V Andrigueti, MD | |
More Information
No publications provided
| Responsible Party: | Cristiane Kayser, Federal University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01347008 History of Changes |
| Other Study ID Numbers: | FAPESP 2011/00012-3 |
| Study First Received: | May 2, 2011 |
| Last Updated: | May 3, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
Sildenafil Endothelial Progenitor Cells Laser Doppler Imaging |
Additional relevant MeSH terms:
|
Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Localized Raynaud Disease Sclerosis Scleroderma, Limited Connective Tissue Diseases Skin Diseases Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Citric Acid |
Sildenafil Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Vasodilator Agents Cardiovascular Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013