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出境医 / 临床实验 / Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus

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

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
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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
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 Name: angiotensin-converting enzyme inhibitor (ACEI)
No Intervention: Control Group
Without ramipril
Outcome Measures
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).


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE September 18, 2013
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date June 10, 2019
Study Start Date  ICMJE March 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • 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
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
Official Title  ICMJE Ramipril Improves Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus: a Randomized and Controlled Study.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE 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)
Study Arms  ICMJE
  • Active Comparator: ramipril group
    Use of ramipril 10mg/day per 12 weeks
    Intervention: Drug: Ramipril
  • No Intervention: Control Group
    Without ramipril
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2019) 		37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979976
Other Study ID Numbers  ICMJE Ramipril.unifesp
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emilia Inoue Sato, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Study Chair: Emilia I Sato, MD, PhD Universidade Federal de São Paulo
PRS Account Federal University of São Paulo
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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