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Ramipril in Rheumatoid Arthritis
This study has been completed.
Study NCT00273533   Information provided by University of Zurich
First Received: January 6, 2006   Last Updated: July 21, 2008   History of Changes

January 6, 2006
July 21, 2008
June 2004
 
Endothelial dysfunction evaluated on weeks 8 and 16.
Same as current
Complete list of historical versions of study NCT00273533 on ClinicalTrials.gov Archive Site
Alteration of inflammatory parameters: C-reactive Protein, TNFa, Interleukin 6 on weeks 8 and 16.
Same as current
 
Ramipril in Rheumatoid Arthritis
Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis

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.

The effect of an 8-week treatment with either ramipril or placebo is studied using a randomized, double-blind, and crossover protocol. After given written informed consent, baseline characteristics including physical examination, ECG, blood sample and a noninvasive assessment of endothelial function are obtained. The patients are randomly assigned to receive either ramipril 10mg (up-titration-scheme: starting with 2.5mg in Week1, then 5mg in Week2 followed by 2-5mg for the final 6 weeks) followed by placebo or vice versa.The individual disease-modifying antirheumatic drug therapy is continued throughout the study. The examinations are repeated after 8 weeks treatment of the first and 8 weeks after the second study drug. At week 1 and 2 in each treatment period a safety visit is scheduled.

Phase II, Phase III
Interventional
Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Crossover Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment
Arthritis, Rheumatoid
Drug: Ramipril
 
Flammer AJ, Sudano I, Hermann F, Gay S, Forster A, Neidhart M, Künzler P, Enseleit F, Périat 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. Epub 2008 Apr 21.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
13
July 2006
 

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • drug abuse
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00273533
 
HOE498/6007
University of Zurich
Sanofi-Aventis
Study Director: Ali Shokry Sanofi-Aventis
University of Zurich
October 2006

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