Overview
Ramipril in Rheumatoid Arthritis
Status:
Completed
Completed
Trial end date:
2006-07-01
2006-07-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of ZurichCollaborator:
SanofiTreatments:
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