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Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Enalapril Maleate

Placebo

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring arterial stiffness, enalapril maleate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Instituto de Investigación en Reumatología y Sistema Músculo Esquelético

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Enalapril Maleate

Placebo

Arm Description

Enalapril Maleate 5 mg every 12 hrs for 90 days.

Substance that lacks in itself therapeutic action.

Outcomes

Primary Outcome Measures

Change in Pulse Wave Velocity (PWV)

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

Secondary Outcome Measures

Change in Cardio-Ankle Vascular Index

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.

Full Information

NCT ID

NCT03667131

First Posted

September 10, 2018

Last Updated

November 12, 2018

Sponsor

University of Guadalajara

1. Study Identification

Unique Protocol Identification Number

NCT03667131

Brief Title

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

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

February 13, 2017 (Actual)

Primary Completion Date

December 8, 2017 (Actual)

Study Completion Date

February 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

arterial stiffness, enalapril maleate

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized, double blind, controlled, parallel groups clinical trial.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Participant, care provider, investigator and outcomes assessor.

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enalapril Maleate

Arm Type

Experimental

Arm Description

Enalapril Maleate 5 mg every 12 hrs for 90 days.

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Substance that lacks in itself therapeutic action.

Intervention Type

Drug

Intervention Name(s)

Enalapril Maleate

Other Intervention Name(s)

Angiotensin converting enzyme inhibitor.

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Inactive drug

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Pulse Wave Velocity (PWV)

Description

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

Time Frame

Baseline and 90 days

Secondary Outcome Measure Information:

Title

Change in Cardio-Ankle Vascular Index

Description

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.

Time Frame

Baseline and 90 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Monica Vázquez-Del Mercado, MD, PhD

Organizational Affiliation

University of Guadalajara

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto de Investigación en Reumatología y Sistema Músculo Esquelético

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44340

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

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Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

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