NCT03979976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2013

Completed
5.7 years until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

2.4 years

First QC Date

September 18, 2013

Last Update Submit

June 6, 2019

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosusendotheliumramipril

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

ramipril group

ACTIVE COMPARATOR

Use of ramipril 10mg/day per 12 weeks

Drug: Ramipril

Control Group

NO INTERVENTION

Without ramipril

Interventions

RamiprilDRUG

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

Also known as: angiotensin-converting enzyme inhibitor (ACEI)
ramipril group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SLE according 1997 modified American College Rheumatology criteria
  • age older than 18 years
  • stable treatment for lupus for at least 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, 04021051, Brazil

Location

Related Publications (1)

  • Oliveira ACD, Arismendi MI, Machado LSG, Sato EI. Ramipril Improves Endothelial Function and Increases the Number of Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus. J Clin Rheumatol. 2022 Oct 1;28(7):349-353. doi: 10.1097/RHU.0000000000001869. Epub 2022 Jun 8.

    PMID: 35662232DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

RamiprilAngiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Emilia I Sato, MD, PhD

    Universidade Federal de São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

September 18, 2013

First Posted

June 10, 2019

Study Start

March 1, 2011

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

June 10, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)