Overview

Ramipril in Rheumatoid Arthritis

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Zurich
Collaborator:
Sanofi
Treatments:
Ramipril
Criteria
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