Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Ramipril

Primary Measures

• Endothelial dysfunction evaluated on weeks 8 and 16.

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Zurich

Overall Clinical Trial Officials and Contacts

Ali Shokry Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00273533

Study ID Number: HOE498/6007

ClinicalTrials.gov Identifier: NCT00273533

Health Authority: Switzerland: Swissmedic