Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

November 12, 2018 updated by: Mónica VázquezdelMercadoEspinosa, University of Guadalajara

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Instituto de Investigación en Reumatología y Sistema Músculo Esquelético

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enalapril Maleate
Enalapril Maleate 5 mg every 12 hrs for 90 days.
Drug: Enalapril Maleate
Enalapril Maleate 5 mg tablet, every 12 hrs for 90 days.
Other Names:
  • Angiotensin converting enzyme inhibitor.
Experimental: Placebo
Substance that lacks in itself therapeutic action.
Drug: Placebo
Placebo 5 mg tablet, every 12 hrs for 90 days.
Other Names:
  • Inactive drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Investigators

  • Principal Investigator: Monica Vázquez-Del Mercado, MD, PhD, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2017

Primary Completion (Actual)

December 8, 2017

Study Completion (Actual)

February 19, 2018

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EEVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for pulse wave velocity will be available.

IPD Sharing Time Frame

Data will be available within one year of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent Review Panel. Requests will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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