Ramipril in Rheumatoid Arthritis

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT00273533
• Collaborator: Sanofi (Industry)
• Enrollment: 13
• Duration (Months): 25

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Drug: Ramipril	Phase 2/Phase 3

Detailed Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis
• Study Start Date: Jun 1, 2004
• Study Completion Date: Jul 1, 2006

Outcome Measures

Primary Outcome Measures

1. Endothelial dysfunction evaluated on weeks 8 and 16. []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• 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

Locations

No locations specified.

Sponsors and Collaborators

• University of Zurich
• Sanofi

Investigators

• Study Director: Ali Shokry, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00273533
• Other Study ID Numbers: HOE498/6007
• First Posted: Jan 9, 2006
• Last Update Posted: Jul 22, 2008
• Last Verified: Oct 1, 2006

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Ramipril

Study Results

No Results Posted as of Jul 22, 2008