Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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The aim of this study was to evaluate the effect of ramipril on the endothelial function and on the number of endothelial progenitor cells (EPCs) in systemic lupus erythematosus (SLE) patients.

Detailed Description
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The early detection of additional risk factor for cardiovascular diseases (CVD) such as endothelial dysfunction and low number of EPC in SLE patients, and an intervention proven effective could reduce the cardiovascular morbidity and mortality. No study assessed the effect of ramipril on endothelial function and EPCs in SLE patients.

Official Title
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Ramipril Improves Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus: a Randomized and Controlled Study.

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Ramipril


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SLE according 1997 modified American College Rheumatology criteria age older than 18 years stable treatment for lupus for at least 3 months Exclusion Criteria: previous coronary artery disease hypertension dyslipidemia (LDL>149 mg/dL) renal insufficiency (creatinine ≥1.4 mg/dL) diabetes smoking obesity (BMI≥30) pregnancy menopause patients taking statins or angiotensin convertor enzyme inhibitor within the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ramipril group<br>Use of ramipril 10mg/day per 12 weeks | Drug: Ramipril<br>* Use of ramipril 10mg/day per 12 weeks. Telephone contact was made in the second and sixth week, to ask about possible side effects and ensure adherence<br>* Other names: angiotensin-converting enzyme inhibitor (ACEI);|
| No Intervention: Control Group<br>Without ramipril | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function - Variation of Flow mediated dilation percentage | Patients were evaluated at baseline and after 12 weeks by high-resolution ultrasound of brachial artery in resting conditions, after reactive hyperaemia (flow-mediated dilation-FMD) and after oral glyceryl trinitrate to assess endothelial function | 12 weeks | 
| Number of endothelial progenitor cells (EPC) | Patients were evaluated at baseline and after 12 weeks. EPCs were evaluated by flow cytometry using anti-CD34 (cluster of differentiation 34) (FITC), anti-CD133 (PE) and anti-kinase domain receptor (KDR) (APC) and by cell culture with quantification of colony formation units (CFUs). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic lupus erythematosus, endothelium, ramipril