Clinical trial NCT03667131: Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.
Official title: Effect of Prophylactic Treatment With Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: arterial stiffness
enalapril maleate
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, controlled, parallel groups clinical trial.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pulse Wave Velocity (PWV)
timeFrame: Baseline and 90 days
Secondary outcomes:
measure: Change in Cardio-Ankle Vascular Index
timeFrame: Baseline and 90 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto de Investigación en Reumatología y Sistema Músculo Esquelético
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Monica Vázquez-Del Mercado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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