Ramipril in Rheumatoid Arthritis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Rheumatoid |
Drug: Ramipril |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis |
- Endothelial dysfunction evaluated on weeks 8 and 16.
- Alteration of inflammatory parameters: C-reactive Protein, TNFa, Interleukin 6 on weeks 8 and 16.
| Enrollment: | 13 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | July 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided by University of Zurich
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00273533 History of Changes |
| Other Study ID Numbers: | HOE498/6007 |
| Study First Received: | January 6, 2006 |
| Last Updated: | July 21, 2008 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Ramipril |
Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013