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Ramipril in Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ramipril
Sponsored by
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Endothelial dysfunction evaluated on weeks 8 and 16.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 6, 2006
    Last Updated
    July 21, 2008
    Sponsor
    University of Zurich
    Collaborators
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00273533
    Brief Title
    Ramipril in Rheumatoid Arthritis
    Official Title
    Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Zurich
    Collaborators
    Sanofi

    4. Oversight

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis, Rheumatoid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ramipril
    Primary Outcome Measure Information:
    Title
    Endothelial dysfunction evaluated on weeks 8 and 16.
    Secondary Outcome Measure Information:
    Title
    Alteration of inflammatory parameters: C-reactive Protein, TNFa, Interleukin 6 on weeks 8 and 16.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ali Shokry
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18427133
    Citation
    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.
    Results Reference
    derived

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    Ramipril in Rheumatoid Arthritis

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