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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil citrate | Active Comparator | Oral Sildenafil citrate, 50mg, b.i.d. |
|
| Sugar pill | Placebo Comparator | Placebo pill (identical to Sildenafil citrate 50mg), b.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil citrate | Drug | Oral sildenafil citratre, 50mg b.i.d., 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Frequency of Raynaud's Phenomenon Attacks | Daily frequency of RP attacks as self registered in a 1-week diary. Any episode of pallor or cyanosis of the hand/fingers was considered as a RP attack, and patients were supposed to register the daily amount of such episodes on a 1-week diary, previously to the medical visit. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando V Andrigueti, MD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Systemic Sclerosis Outpatient Clinic, Hospital Sao Paulo, UNIFESP | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37929840 | Derived | 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. |
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Patients recruited at the Outpatient Clinic of The Federal University of Sao Paulo, between August 2011 and November 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil Citrate | Oral Sildenafil citrate, 50mg, b.i.d. Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks |
| FG001 | Sugar Pill | Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo (Sugar pill) | Drug | Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil Citrate | Oral Sildenafil citrate, 50mg, b.i.d. Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks |
| BG001 | Sugar Pill | Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| 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.). | Mean | Standard Deviation | perfusion units |
| ||||||||||||||
| Digital skin microvascular blood flow measured by Laser Doppler Imaging (LDI) after cold stimulus. | Finger blood flow of the four medial fingers, measured by laser Doppler imaging and expressed in arbitrary perfusion units (p.u.). Measure taken after submersion of both hands in water at 15°C for 1 minute. | Mean | Standard Deviation | perfusion units |
| ||||||||||||||
| Daily frequency of Raynuad's Phenomenon attacks | Daily frequency of RP attacks as self registered in a 1-week diary. Any episode of pallor or cyanosis of the hand/fingers was considered as a RP attack, and patients were supposed to register the daily amount of such episodes on a 1-week diary, previously to the medical visit. | Mean | Standard Deviation | number of attacks per day |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.). | Posted | Mean | Standard Deviation | perfusion units | 8 weeks |
|
|
| |||||||||||||||||||||||||||||
| Primary | Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus. | Posted | Mean | Standard Deviation | perfusion units | 8 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | Daily Frequency of Raynaud's Phenomenon Attacks | Daily frequency of RP attacks as self registered in a 1-week diary. Any episode of pallor or cyanosis of the hand/fingers was considered as a RP attack, and patients were supposed to register the daily amount of such episodes on a 1-week diary, previously to the medical visit. | Posted | Mean | Standard Deviation | number of attacks per day | 8 weeks |
|
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sildenafil Citrate | Oral Sildenafil citrate, 50mg, b.i.d. Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks | 0 | 21 | 7 | 21 | ||
| EG001 | Sugar Pill | Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks | 0 | 20 | 1 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
Small numbers of subjects analyzed; blood flow differences due to outside temperature variations
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fernando Villela Andrigueti, MD | Federal University of Sao Paulo | +55 11 55764239 | fernando.andrigueti@usp.br |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D045743 | Scleroderma, Diffuse |
| D045745 | Scleroderma, Limited |
| D011928 | Raynaud Disease |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| D036881 | Long-Term Synaptic Depression |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D002241 | Carbohydrates |
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| Male |
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