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OpenTrials
Completed

NCT Number: NCT03667131

Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Instituto de Investigación en Reumatología y Sistema Músculo Esquelético

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

enalapril maleate

Drug

Enalapril Maleate 5 mg tablet, every 12 hrs for 90 days.

Other names: Angiotensin converting enzyme inhibitor.

Placebo

Drug

Placebo 5 mg tablet, every 12 hrs for 90 days.

Other names: Inactive drug

Primary outcomes

  1. Change in Pulse Wave Velocity (PWV)

    Time frame: Baseline and 90 days

    This is a measure of arterial stiffness, or the rate at which pressure waves move down the vessel.

Secondary outcomes

  1. Change in Cardio-Ankle Vascular Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Sep 12, 2018
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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