Systemic Lupus Erythematous and Heart Conduction Disorders

NCT02162992 | Completed Results

• 1 other identifier: ICOR-2014-01
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

Connective tissue diseases have been related to heart conduction disorders. The anti-Ro/SSA antibodies are thought to have a pathogenic role, and they most prevalent in systemic lupus erythematous (SLE). The aim of this study is to evaluate the relationship between SLE, arrhythmias and its serologic profile.

Conditions

Lupus Erythematosus, Systemic; Atrioventricular Block; Sudden Death

Keywords

Antibodies, Antinuclear; SS-A antigen; Lupus Erythematosus, Systemic; Atrioventricular Block; Sudden death

Outcome Measures

Primary Outcomes (1)

• Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile

  Conduction disorders will be evaluated by 12-lead ECG recordings an 24-hour Holter recordings. Measurements will include PR intervals (in msec), QRS duration (in msec) .

  24 hours

Secondary Outcomes (1)

• QT and Corrected QT Intervals

  24 hours

Study Arms (2)

SLE and Anti-Ro antibodies Group

Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)

Other: No intervention

SLE without Anti-Ro antibodies Group

Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)

Other: No intervention

Interventions

No intervention OTHER

Observational

SLE and Anti-Ro antibodies Group; SLE without Anti-Ro antibodies Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with SLE visited in the rheumatology outpatient's area.

You may qualify if:

• Patients with SLE diagnosis, according to SLE diagnostic criteria.

You may not qualify if:

• Patients with previous cardiac diseases (ischemic heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, valvular heart disease)
• Clinical history of heart surgery or ablation procedures
• Clinical history of other conditions that affect heart conduction:
• Steinert Disease
• Lyme Disease
• Chagas Disease
• Hypothyroidism

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Germans Trias i Pujol University Hospital

Badalona, Barcelona, 08916, Spain

Location

Related Publications (16)

• Lazzerini PE, Capecchi PL, Laghi-Pasini F. Anti-Ro/SSA antibodies and cardiac arrhythmias in the adult: facts and hypotheses. Scand J Immunol. 2010 Sep;72(3):213-22. doi: 10.1111/j.1365-3083.2010.02428.x.

  PMID: 20696018 BACKGROUND

• Chameides L, Truex RC, Vetter V, Rashkind WJ, Galioto FM Jr, Noonan JA. Association of maternal systemic lupus erythematosus with congenital complete heart block. N Engl J Med. 1977 Dec 1;297(22):1204-7. doi: 10.1056/NEJM197712012972203.

  PMID: 917056 BACKGROUND

• Seferovic PM, Ristic AD, Maksimovic R, Simeunovic DS, Ristic GG, Radovanovic G, Seferovic D, Maisch B, Matucci-Cerinic M. Cardiac arrhythmias and conduction disturbances in autoimmune rheumatic diseases. Rheumatology (Oxford). 2006 Oct;45 Suppl 4:iv39-42. doi: 10.1093/rheumatology/kel315.

  PMID: 16980722 BACKGROUND

• Edwards CS, Mootoo R, Bhanji A. High grade heart block in association with SLE. Ann Rheum Dis. 2004 May;63(5):606. doi: 10.1136/ard.2002.005322. No abstract available.

  PMID: 15082501 BACKGROUND

• Costedoat-Chalumeau N, Georgin-Lavialle S, Amoura Z, Piette JC. Anti-SSA/Ro and anti-SSB/La antibody-mediated congenital heart block. Lupus. 2005;14(9):660-4. doi: 10.1191/0961203305lu2195oa.

  PMID: 16218462 BACKGROUND

• Santos-Pardo I, Martinez-Morillo M, Villuendas R, Bayes-Genis A. Anti-Ro antibodies and reversible atrioventricular block. N Engl J Med. 2013 Jun 13;368(24):2335-7. doi: 10.1056/NEJMc1300484. No abstract available.

  PMID: 23758256 BACKGROUND

• Behan WM, Behan PO, Gairns J. Cardiac damage in polymyositis associated with antibodies to tissue ribonucleoproteins. Br Heart J. 1987 Feb;57(2):176-80. doi: 10.1136/hrt.57.2.176.

  PMID: 3493020 BACKGROUND

• Logar D, Kveder T, Rozman B, Dobovisek J. Possible association between anti-Ro antibodies and myocarditis or cardiac conduction defects in adults with systemic lupus erythematosus. Ann Rheum Dis. 1990 Aug;49(8):627-9. doi: 10.1136/ard.49.8.627.

  PMID: 2396870 BACKGROUND

• O'Neill TW, Mahmoud A, Tooke A, Thomas RD, Maddison PJ. Is there a relationship between subclinical myocardial abnormalities, conduction defects and Ro/La antibodies in adults with systemic lupus erythematosus? Clin Exp Rheumatol. 1993 Jul-Aug;11(4):409-12.

  PMID: 8403587 BACKGROUND

• Lodde BM, Sankar V, Kok MR, Leakan RA, Tak PP, Pillemer SR. Adult heart block is associated with disease activity in primary Sjogren's syndrome. Scand J Rheumatol. 2005 Sep-Oct;34(5):383-6. doi: 10.1080/03009740510026661.

  PMID: 16234186 BACKGROUND

• Costa M, Gameiro Silva MB, Silva JA, Skare TL. Anti-RO anti-LA anti-RNP antibodies and eletrocardiogram's PR interval in adult patients with systemic lupus erythematosus. Acta Reumatol Port. 2008 Apr-Jun;33(2):173-6.

  PMID: 18604183 BACKGROUND

• Lazzerini PE, Capecchi PL, Guideri F, Acampa M, Galeazzi M, Laghi Pasini F. Connective tissue diseases and cardiac rhythm disorders: an overview. Autoimmun Rev. 2006 May;5(5):306-13. doi: 10.1016/j.autrev.2005.11.002. Epub 2005 Dec 9.

  PMID: 16782554 BACKGROUND

• Lazzerini PE, Capecchi PL, Acampa M, Morozzi G, Bellisai F, Bacarelli MR, Dragoni S, Fineschi I, Simpatico A, Galeazzi M, Laghi-Pasini F. Anti-Ro/SSA-associated corrected QT interval prolongation in adults: the role of antibody level and specificity. Arthritis Care Res (Hoboken). 2011 Oct;63(10):1463-70. doi: 10.1002/acr.20540.

  PMID: 21739618 BACKGROUND

• Villuendas R, Olive A, Junca G, Salvador I, Martinez-Morillo M, Santos-Pardo I, Pereferrer D, Zamora E, Bayes-Genis A. Autoimmunity and atrioventricular block of unknown etiology in adults: the role of anti-Ro/SSA antibodies. J Am Coll Cardiol. 2014 Apr 8;63(13):1335-1336. doi: 10.1016/j.jacc.2013.10.086. Epub 2014 Jan 30. No abstract available.

  PMID: 24486277 BACKGROUND

• Gordon PA, Rosenthal E, Khamashta MA, Hughes GR. Absence of conduction defects in the electrocardiograms [correction of echocardiograms] of mothers with children with congenital complete heart block. J Rheumatol. 2001 Feb;28(2):366-9.

  PMID: 11246679 BACKGROUND

• Villuendas R, Martinez-Morillo M, Junca G, Teniente-Serra A, Diez C, Heredia S, Riveros-Frutos A, Bayes-Genis A, Olive A. Usefulness of cardiac screening in patients with systemic lupus erythematosus and anti-Ro/SSA antibodies. Lupus. 2021 Sep;30(10):1596-1602. doi: 10.1177/09612033211027928. Epub 2021 Jul 1.

  PMID: 34192953 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Atrioventricular Block; Death, Sudden

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death

Results Point of Contact

• Title: Dr. Roger Villuendas
• Organization: H. Germans Trias i Pujol

rogervilluendas@hotmail.com

+34 4978398

Study Officials

• Roger Villuendas

  GTIPUH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the Electrophysiology and Cardiac Pacing Unit

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: June 13, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: April 1, 2018
• Last Updated: October 28, 2019
• Results First Posted: October 28, 2019

Record last verified: 2019-10

Locations

ES (1)