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

Federal University of São Paulo

Status and phase: Completed; Phase 3; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Ramipril

Study type: Interventional

Funder types: Other

Identifiers

NCT03979976

Ramipril.unifesp

Details and patient eligibility

About

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 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.

Enrollment: 37 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 2 patient groups

ramipril group

Active Comparator group

Description:

Use of ramipril 10mg/day per 12 weeks

Treatment:

Drug: Ramipril

Control Group

No Intervention group

Description:

Without ramipril