Ramipril in Rheumatoid Arthritis

University of Zurich13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Arthritis, Rheumatoid

Interventions

RamiprilDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Endothelial dysfunction evaluated on weeks 8 and 16.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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