Enalapril Maleate on Arterial Stiffness in Rheumatoid Art... | NCT03667131

Studies
Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

NCT03667131

Sponsor

University of Guadalajara

Status

Completed

Last Update Posted

Nov 14, 2018Actual

Enrollment

59Actual

Phase

Phase 2

Conditions

Rheumatoid Arthritis

Interventions

Enalapril Maleate
Placebo

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2017Actual

Primary Completion Date

Dec 8, 2017Actual

Completion Date

Feb 19, 2018Actual

First Submitted Date

Sep 10, 2018

First Submission Date that Met QC Criteria

Sep 10, 2018

First Posted Date

Sep 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2018

Last Update Posted Date

Nov 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enalapril Maleate	Experimental	Enalapril Maleate 5 mg every 12 hrs for 90 days.	Drug: Enalapril Maleate
Placebo	Experimental	Substance that lacks in itself therapeutic action.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enalapril Maleate	Drug	Enalapril Maleate 5 mg tablet, every 12 hrs for 90 days.	Enalapril Maleate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Pulse Wave Velocity (PWV)	This is a measure of arterial stiffness, or the rate at which pressure waves move down the vessel.	Baseline and 90 days

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline and 90 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Monica Vázquez-Del Mercado, MD, PhD	University of Guadalajara	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Investigación en Reumatología y Sistema Músculo Esquelético		Guadalajara	Jalisco	44340	Mexico

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26509052	Background	Gossec L, Dougados M, Dixon W. Patient-reported outcomes as end points in clinical trials in rheumatoid arthritis. RMD Open. 2015 Apr 2;1(1):e000019. doi: 10.1136/rmdopen-2014-000019. eCollection 2015.
24217582	Background	Burmester GR, Feist E, Dorner T. Emerging cell and cytokine targets in rheumatoid arthritis. Nat Rev Rheumatol. 2014 Feb;10(2):77-88. doi: 10.1038/nrrheum.2013.168. Epub 2013 Nov 12.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D004656	Enalapril
D000806	Angiotensin-Converting Enzyme Inhibitors

ID	Term
D004151	Dipeptides
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins