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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT03979976

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Location

Arms

30.1

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: Ramipril	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ramipril group Use of ramipril 10mg/day per 12 weeks	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 Other Names: angiotensin-converting enzyme inhibitor (ACEI)
No Intervention: Control Group Without ramipril

Arm

Intervention/Treatment

Active Comparator: ramipril group

Use of ramipril 10mg/day per 12 weeks

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

Other Names:

angiotensin-converting enzyme inhibitor (ACEI)

No Intervention: Control Group

Without ramipril

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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