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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Ramipril
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Systemic Lupus Erythematosus focused on measuring systemic lupus erythematosus, endothelium, ramipril

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ramipril group

Control Group

Arm Description

Use of ramipril 10mg/day per 12 weeks

Without ramipril

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

Full Information

First Posted
September 18, 2013
Last Updated
June 6, 2019
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03979976
Brief Title
Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
Official Title
Ramipril Improves Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus: a Randomized and Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
systemic lupus erythematosus, endothelium, ramipril

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ramipril group
Arm Type
Active Comparator
Arm Description
Use of ramipril 10mg/day per 12 weeks
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Without ramipril
Intervention Type
Drug
Intervention Name(s)
Ramipril
Other Intervention Name(s)
angiotensin-converting enzyme inhibitor (ACEI)
Intervention Description
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
Primary Outcome Measure Information:
Title
Endothelial function - Variation of Flow mediated dilation percentage
Description
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
Time Frame
12 weeks
Title
Number of endothelial progenitor cells (EPC)
Description
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).
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilia I Sato, MD, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04021051
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35662232
Citation
Oliveira ACD, Arismendi MI, Machado LSG, Sato EI. Ramipril Improves Endothelial Function and Increases the Number of Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus. J Clin Rheumatol. 2022 Oct 1;28(7):349-353. doi: 10.1097/RHU.0000000000001869. Epub 2022 Jun 8.
Results Reference
derived

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

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