Ramipril in Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ramipril

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ali Shokry

Role: STUDY_DIRECTOR

Sanofi

Countries

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Switzerland

References

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Flammer AJ, Sudano I, Hermann F, Gay S, Forster A, Neidhart M, Kunzler P, Enseleit F, Periat D, Hermann M, Nussberger J, Luscher TF, Corti R, Noll G, Ruschitzka F. Angiotensin-converting enzyme inhibition improves vascular function in rheumatoid arthritis. Circulation. 2008 Apr 29;117(17):2262-9. doi: 10.1161/CIRCULATIONAHA.107.734384. Epub 2008 Apr 21.

Reference Type DERIVED

PMID: 18427133 (View on PubMed)

Other Identifiers

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HOE498/6007

Identifier Type: -

Identifier Source: org_study_id