Rheumatoid Arthritis
Conditions
Keywords
arterial stiffness, enalapril maleate
Brief summary
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
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.
Interventions
Enalapril Maleate 5 mg tablet, every 12 hrs for 90 days.
DRUGPlacebo
Placebo 5 mg tablet, every 12 hrs for 90 days.
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participant, care provider, investigator and outcomes assessor.
Intervention model description
Randomized, double blind, controlled, parallel groups clinical trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulse Wave Velocity (PWV) | Baseline and 90 days | This is a measure of arterial stiffness, or the rate at which pressure waves move down the vessel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardio-Ankle Vascular Index | Baseline and 90 days | 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. |
Countries
Mexico
Outcome results
None listed