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Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

U

University of Guadalajara

Status and phase

Completed
Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: Placebo
Drug: Enalapril Maleate

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

59 participants in 2 patient groups

Enalapril Maleate
Experimental group
Description:
Enalapril Maleate 5 mg every 12 hrs for 90 days.
Treatment:
Drug: Enalapril Maleate
Placebo
Experimental group
Description:
Substance that lacks in itself therapeutic action.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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