NCT00273533

Brief Summary

The present study is designed to evaluate the hypothesis that the Angiotensin-Converting Enzyme (ACE) inhibitor Ramipril improves vascular function and reduces markers of low-grade chronic inflammation and oxidative stress in patients with Rheumatoid Arthritis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2004

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

June 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

July 22, 2008

Status Verified

October 1, 2006

First QC Date

January 6, 2006

Last Update Submit

July 21, 2008

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • Endothelial dysfunction evaluated on weeks 8 and 16.

Secondary Outcomes (1)

  • Alteration of inflammatory parameters: C-reactive Protein, TNFa, Interleukin 6 on weeks 8 and 16.

Interventions

RamiprilDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with rheumatoid arthritis (4 out of 7 ARA criteria must be fulfilled to establish diagnosis) on stable background therapy for the last three months
  • endothelial dysfunction (FMD \< 4%, FMD:Flow-Mediated-Dilatation)
  • non-smokers

You may not qualify if:

  • previous myocardial infarction, coronary intervention or coronary surgery
  • previous treatment with statins in the last 6 months
  • previous treatment with ACE-inhibitors in the last 6 months
  • uncontrolled hypertension SAP/DAP \> 160/90 mmHg (SAP:Systolic Arterial Pressure, DAP:Diastolic Arterial Pressure)
  • dyslipidemia (LDL-cholesterol \> 4.9 mmol)
  • normal CRP \< 3 mg/l
  • overweight BMI \> 35kg/m2
  • anaemia (hemoglobin \< 10g/dl)
  • kidney disease (creatinine \> 150 umol/l)
  • insulin-dependent diabetes mellitus
  • congestive heart failure (\> NYHA I)
  • AV-Block\>I
  • pregnancy
  • angio-edema
  • malignancy or chronic infection
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Flammer AJ, Sudano I, Hermann F, Gay S, Forster A, Neidhart M, Kunzler P, Enseleit F, Periat D, Hermann M, Nussberger J, Luscher TF, Corti R, Noll G, Ruschitzka F. Angiotensin-converting enzyme inhibition improves vascular function in rheumatoid arthritis. Circulation. 2008 Apr 29;117(17):2262-9. doi: 10.1161/CIRCULATIONAHA.107.734384. Epub 2008 Apr 21.

    PMID: 18427133DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Ramipril

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ali Shokry

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 9, 2006

Study Start

June 1, 2004

Study Completion

July 1, 2006

Last Updated

July 22, 2008

Record last verified: 2006-10