Arthritis, Rheumatoid
Conditions
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.
Detailed description
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.
Interventions
DRUGRamipril
Sponsors
Sanofi
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial dysfunction evaluated on weeks 8 and 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Alteration of inflammatory parameters: C-reactive Protein, TNFa, Interleukin 6 on weeks 8 and 16. | — |
Outcome results
None listed