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

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Ramipril

• Registration Number: NCT03979976
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2013-08
• Study Completion: 2013-09
• Study First Submitted: 2013-09-18
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Study First Posted: 2019-06-10
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

• SLE according 1997 modified American College Rheumatology criteria
• age older than 18 years
• stable treatment for lupus for at least 3 months

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ramipril group	Ramipril	Use of ramipril 10mg/day per 12 weeks

Primary Outcome Measures

Name	Time	Method
Endothelial function - Variation of Flow mediated dilation percentage	12 weeks	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
Number of endothelial progenitor cells (EPC)	12 weeks	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).

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil