Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

Study Overview
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Brief Summary
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This study evaluates the effect in artery stiffness of enalapril maleate in Rheumatoid Arthritis women patients. Half of participants will receive 5 mg enalapril maleate every 12 hrs, while the other half will receive a placebo.

Detailed Description
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Rheumatoid Arthritis (RA) is a chronic inflammatory systemic disease considered as an independent cardiovascular risk factor that is associated with cumulative inflammatory load with an elevation of circulating levels of cytokines, which mediate the mechanism of endothelial cells activation by increasing the angiotensin converting enzyme (ACE) function and generation of vasoconstriction. Enalapril maleate is a prodrug that is hydrolyzed by hepatic esterases in enalaprilat, which is a potent inhibitor of ACE. ACE inhibition decreases vascular systemic resistance and mean, diastolic and systolic blood pressures in several hypertensive states, independently of the mechanism, ACE inhibitors have a widespread clinic use for cardiovascular diseases. Therefore, the researchers considered that there could be an association between the use of enalapril and the decrease in arterial stiffness.

Official Title
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Effect of Prophylactic Treatment With Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis Patients.

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Enalapril Maleate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients classified with RA according to the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) 2010 Patients treated in the outpatient service of the Rheumatology Service of the Hospital Civil de Guadalajara Dr. Juan I Menchaca. Sign an Informed Consent Letter Under treatment with conventional Disease-Modifying Antirheumatic Drugs (DMARDS) Exclusion Criteria: Patients with a previous diagnosis of diabetes mellitus, systemic hypertension, thyroid, kidney or liver disease History of acute myocardial infarction, cardiac arrhythmias, cerebral vascular event or heart failure Smoking active patients in the last 6 months Patients with a desire for close conception, pregnant or breastfeeding. Patients with blood pressure <90/60 mmHg Patients who do not accept to participate in the study Patients with a BMI greater than ≥40 Kg / m2 Non-palpable carotid and femoral pulses Unstable psychological state

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double blind, controlled, parallel groups clinical trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enalapril Maleate<br>Enalapril Maleate 5 mg every 12 hrs for 90 days. | Drug: Enalapril Maleate<br>* Enalapril Maleate 5 mg tablet, every 12 hrs for 90 days.<br>* Other names: Angiotensin converting enzyme inhibitor.;|
| Experimental: Placebo<br>Substance that lacks in itself therapeutic action. | Drug: Placebo<br>* Placebo 5 mg tablet, every 12 hrs for 90 days.<br>* Other names: Inactive drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pulse Wave Velocity (PWV) | This is a measure of arterial stiffness, or the rate at which pressure waves move down the vessel. | Baseline and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardio-Ankle Vascular Index | This is calculated from PWV at the origin of the aorta to the ankle portion of the tibial artery, and systolic and diastolic blood pressures measured at the upper brachial artery. | Baseline and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arterial stiffness, enalapril maleate