Ramipril in Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273533
• Other study ID #: HOE498/6007
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 6, 2006
• Last updated: July 21, 2008
• Start date: June 2004
• Est. completion date: July 2006

Study information

• Verified date: October 2006
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2006
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Ramipril

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Sanofi

Outcome

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.