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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979976
• Other study ID #: Ramipril.unifesp
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2011
• Est. completion date: September 2013

Study information

• Verified date: June 2019
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks
Primary	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).	12 weeks