Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.
NCT ID: NCT03667131
Last Updated: 2018-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2017-02-13
2018-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Enalapril Maleate
Enalapril Maleate 5 mg every 12 hrs for 90 days.
Enalapril Maleate
Enalapril Maleate 5 mg tablet, every 12 hrs for 90 days.
Placebo
Substance that lacks in itself therapeutic action.
Placebo
Placebo 5 mg tablet, every 12 hrs for 90 days.
Interventions
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Enalapril Maleate
Enalapril Maleate 5 mg tablet, every 12 hrs for 90 days.
Placebo
Placebo 5 mg tablet, every 12 hrs for 90 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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University of Guadalajara
OTHER
Responsible Party
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Mónica VázquezdelMercadoEspinosa
PhD
Principal Investigators
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Monica Vázquez-Del Mercado, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Guadalajara
Locations
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Instituto de Investigación en Reumatología y Sistema Músculo Esquelético
Guadalajara, Jalisco, Mexico
Countries
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References
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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.
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.
Gibofsky A. Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis. Am J Manag Care. 2012 Dec;18(13 Suppl):S295-302.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Perez-Vazquez F, Back M, Chavarria-Avila E, Gomez-Banuelos E, Ramos-Becerra CG, Pizano-Martinez O, Salazar-Paramo M, Grover-Paez F, Nava-Zavala AH, Cardona-Munoz EG, Cardona-Muller D, Duran-Barragan S, Mera-Riofrio VN, Prado-Bachega N, Vazquez-Del Mercado M. Enalapril Influence on Arterial Stiffness in Rheumatoid Arthritis Women: A Randomized Clinical Trial. Front Med (Lausanne). 2020 Jan 29;6:341. doi: 10.3389/fmed.2019.00341. eCollection 2019.
Other Identifiers
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EEVA
Identifier Type: -
Identifier Source: org_study_id
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