Arthritis, Rheumatoid Clinical Trial
Official title:
Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis
Verified date | October 2006 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
The present study is designed to evaluate the hypothesis that the AngiotensināConverting Enzyme (ACE) inhibitor Ramipril improves vascular function and reduces markers of low-grade chronic inflammation and oxidative stress in patients with Rheumatoid Arthritis.
Status | Completed |
Enrollment | 13 |
Est. completion date | July 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | Sanofi |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endothelial dysfunction evaluated on weeks 8 and 16. | |||
Secondary | Alteration of inflammatory parameters: C-reactive Protein, TNFa, Interleukin 6 on weeks 8 and 16. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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