Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: Enalapril Maleate

• Registration Number: NCT03667131
• Lead Sponsor: University of Guadalajara

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.

Study Timeline

• Study Start: 2017-02-13
• Primary Completion: 2017-12-08
• Study Completion: 2018-02-19
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Substance that lacks in itself therapeutic action.
Enalapril Maleate	Enalapril Maleate	Enalapril Maleate 5 mg every 12 hrs for 90 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Instituto de Investigación en Reumatología y Sistema Músculo Esquelético; 🇲🇽 Guadalajara, Jalisco, Mexico