Ramipril in Rheumatoid Arthritis - Full Text View

Sponsors and Collaborators:	University of Zurich Sanofi-Aventis
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00273533

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 II Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Ramipril

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis

Further study details as provided by University of Zurich:

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.

Enrollment:	13
Study Start Date:	June 2004
Estimated Study Completion Date:	July 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273533

Sponsors and Collaborators

University of Zurich

Sanofi-Aventis

Investigators

Study Director:

Ali Shokry

Sanofi-Aventis

More Information

Publications indexed to this study:

Flammer AJ, Sudano I, Hermann F, Gay S, Forster A, Neidhart M, Künzler P, Enseleit F, Périat 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. Epub 2008 Apr 21.

Study ID Numbers:	HOE498/6007
Study First Received:	January 6, 2006
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00273533
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Ramipril

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009