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

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ClinicalTrials.gov Identifier: NCT03979976
Recruitment Status : Completed
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Emilia Inoue Sato, Federal University of São Paulo

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: 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 Name: angiotensin-converting enzyme inhibitor (ACEI)

No Intervention: Control Group
Without ramipril



Primary Outcome Measures :
  1. 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

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979976


Locations
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Brazil
Federal University of São Paulo
São Paulo, Brazil, 04021051
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Study Chair: Emilia I Sato, MD, PhD Universidade Federal de São Paulo

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Responsible Party: Emilia Inoue Sato, Full professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03979976     History of Changes
Other Study ID Numbers: Ramipril.unifesp
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Emilia Inoue Sato, Federal University of São Paulo:
systemic lupus erythematosus
endothelium
ramipril

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents