Ramipril in Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: Ramipril


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ramipril|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial dysfunction evaluated on weeks 8 and 16. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration of inflammatory parameters: C-reactive Protein, TNFa, Interleukin 6 on weeks 8 and 16. |  |  |