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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2013

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.

Interventions

  • Drug: Ramipril
    • 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

Arms, Groups and Cohorts

  • Active Comparator: ramipril group
    • Use of ramipril 10mg/day per 12 weeks
  • No Intervention: Control Group
    • Without ramipril

Clinical Trial Outcome Measures

Primary Measures

  • Endothelial function – Variation of Flow mediated dilation percentage
    • Time Frame: 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)
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Collaborator
    • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Emilia Inoue Sato, Full professor – Federal University of São Paulo
  • Overall Official(s)
    • Emilia I Sato, MD, PhD, Study Chair, Universidade Federal de São Paulo

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