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Rheumatoid ArthritisPhase 2NCT03667131

Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

A Phase 2 study testing Enalapril Maleate in people with Rheumatoid Arthritis, run by University of Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Enalapril Maleate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
1 siteMexico
Study dates
13 Feb 2017to 19 Feb 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • Patients with a BMI greater than ≥40 Kg / m2
  • Non-palpable carotid and femoral pulses
  • Unstable psychological state

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto de Investigación en Reumatología y Sistema Músculo Esquelético

    Guadalajara, Jalisco, 44340

Other trials in Mexico

About this study

Official title: 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.

Read the 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.

Being tested
Enalapril Maleate, Placebo
Keywords
arterial stiffness, enalapril maleate
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enalapril MaleateDrug

    Also called Angiotensin converting enzyme inhibitor.

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

  • PlaceboDrug

    Also called Inactive drug

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

Study groups in NCT03667131
Study groupRoleWhat they receive
Enalapril MaleateExperimentalEnalapril Maleate 5 mg every 12 hrs for 90 days.
Receives: Drug: Enalapril Maleate
PlaceboExperimentalSubstance that lacks in itself therapeutic action.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pulse Wave Velocity (PWV)

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

    Measured: Baseline and 90 days

Secondary outcomes (1)

  1. 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.

    Measured: Baseline and 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start13 Feb 2017
  3. Primary completion8 Dec 2017
  4. Study completion19 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double blind, controlled, parallel groups clinical trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03667131
Sponsor's protocol ID
EEVA
Status last verified
Nov 2018
First submitted
10 Sep 2018
Last updated
14 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for pulse wave velocity will be available.

Publications

  • 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.

    PubMed 26509052

  • 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.

    PubMed 24217582

  • Gibofsky A. Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis. Am J Manag Care. 2012 Dec;18(13 Suppl):S295-302.

    PubMed 23327517

  • Gkaliagkousi E, Gavriilaki E, Doumas M, Petidis K, Aslanidis S, Stella D. Cardiovascular risk in rheumatoid arthritis: pathogenesis, diagnosis, and management. J Clin Rheumatol. 2012 Dec;18(8):422-30. doi: 10.1097/RHU.0b013e31827846b1.

    PubMed 23188207

  • Solomon DH, Karlson EW, Rimm EB, Cannuscio CC, Mandl LA, Manson JE, Stampfer MJ, Curhan GC. Cardiovascular morbidity and mortality in women diagnosed with rheumatoid arthritis. Circulation. 2003 Mar 11;107(9):1303-7. doi: 10.1161/01.cir.0000054612.26458.b2.

    PubMed 12628952

  • Kramer HR, Giles JT. Cardiovascular disease risk in rheumatoid arthritis: progress, debate, and opportunity. Arthritis Care Res (Hoboken). 2011 Apr;63(4):484-99. doi: 10.1002/acr.20386. No abstract available.

    PubMed 21452262

  • Crowson CS, Nicola PJ, Kremers HM, O'Fallon WM, Therneau TM, Jacobsen SJ, Roger VL, Ballman KV, Gabriel SE. How much of the increased incidence of heart failure in rheumatoid arthritis is attributable to traditional cardiovascular risk factors and ischemic heart disease? Arthritis Rheum. 2005 Oct;52(10):3039-44. doi: 10.1002/art.21349.

    PubMed 16200583

  • Kremers HM, Crowson CS, Therneau TM, Roger VL, Gabriel SE. High ten-year risk of cardiovascular disease in newly diagnosed rheumatoid arthritis patients: a population-based cohort study. Arthritis Rheum. 2008 Aug;58(8):2268-74. doi: 10.1002/art.23650.

    PubMed 18668561

  • Crilly MA, Kumar V, Clark HJ, Scott NW, Macdonald AG, Williams DJ. Arterial stiffness and cumulative inflammatory burden in rheumatoid arthritis: a dose-response relationship independent of established cardiovascular risk factors. Rheumatology (Oxford). 2009 Dec;48(12):1606-12. doi: 10.1093/rheumatology/kep305. Epub 2009 Oct 25.

    PubMed 19858120

  • Klocke R, Cockcroft JR, Taylor GJ, Hall IR, Blake DR. Arterial stiffness and central blood pressure, as determined by pulse wave analysis, in rheumatoid arthritis. Ann Rheum Dis. 2003 May;62(5):414-8. doi: 10.1136/ard.62.5.414.

    PubMed 12695151

  • Park S, Lakatta EG. Role of inflammation in the pathogenesis of arterial stiffness. Yonsei Med J. 2012 Mar;53(2):258-61. doi: 10.3349/ymj.2012.53.2.258.

    PubMed 22318811

  • Roman MJ, Devereux RB, Schwartz JE, Lockshin MD, Paget SA, Davis A, Crow MK, Sammaritano L, Levine DM, Shankar BA, Moeller E, Salmon JE. Arterial stiffness in chronic inflammatory diseases. Hypertension. 2005 Jul;46(1):194-9. doi: 10.1161/01.HYP.0000168055.89955.db. Epub 2005 May 23.

    PubMed 15911740

  • Vazquez-Del Mercado M, Nunez-Atahualpa L, Figueroa-Sanchez M, Gomez-Banuelos E, Rocha-Munoz AD, Martin-Marquez BT, Corona-Sanchez EG, Martinez-Garcia EA, Macias-Reyes H, Gonzalez-Lopez L, Gamez-Nava JI, Navarro-Hernandez RE, Nunez-Atahualpa MA, Andrade-Garduno J. Serum levels of anticyclic citrullinated peptide antibodies, interleukin-6, tumor necrosis factor-alpha, and C-reactive protein are associated with increased carotid intima-media thickness: a cross-sectional analysis of a cohort of rheumatoid arthritis patients without cardiovascular risk factors. Biomed Res Int. 2015;2015:342649. doi: 10.1155/2015/342649. Epub 2015 Mar 2.

    PubMed 25821796

  • Wallberg-Jonsson S, Caidahl K, Klintland N, Nyberg G, Rantapaa-Dahlqvist S. Increased arterial stiffness and indication of endothelial dysfunction in long-standing rheumatoid arthritis. Scand J Rheumatol. 2008 Jan-Feb;37(1):1-5. doi: 10.1080/03009740701633238.

    PubMed 18189187

  • Vazquez-Del Mercado M, Gomez-Banuelos E, Chavarria-Avila E, Cardona-Munoz E, Ramos-Becerra C, Alanis-Sanchez A, Cardona-Muller D, Grover-Paez F, Perez-Vazquez FJ, Navarro-Hernandez RE, Valadez-Soto JM, Saldana-Millan AA, Gonzalez-Rosas L, Ramos-Lopez G, Petri MH, Back M. Disease duration of rheumatoid arthritis is a predictor of vascular stiffness: a cross-sectional study in patients without known cardiovascular comorbidities: A STROBE-compliant article. Medicine (Baltimore). 2017 Aug;96(33):e7862. doi: 10.1097/MD.0000000000007862.

    PubMed 28816989

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enalapril Maleate in people with Rheumatoid Arthritis, run by University of Guadalajara at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pulse Wave Velocity (PWV) (time frame: Baseline and 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03667131, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.

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