Systemic Lupus Erythematous and Heart Conduction Disorders

Lupus Erythematosus, Systemic Clinical Trial

Official title:

Repolarization Disorders and Heart Conduction Disorders in Patients With Systemic Lupus Erythematous

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162992
• Other study ID #: ICOR-2014-01
• Status: Completed
• Start date: April 2014
• Est. completion date: April 2018

Study information

• Verified date: October 2019
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

We designed a cross-sectional study for an observational analysis. The target population will be the group of SLE patients visited the service of Rheumatology hospitals in Catalonia (Spain).

The criteria for subjects selection to participate in our project are:

1 . Inclusion criteria: patients with SLE according to established diagnostic criteria in 1997 2. Exclusion criteria:

• Presence of cardiac: Ischemic heart disease or congenital or acquired structural heart disease (hypertrophic cardiomyopathy, idiopathic dilated cardiomyopathy, valve disease with clinical significance).

• Background heart surgery or cardiac ablation procedures.

• Background in other pathological processes has been described affecting cardiac conduction tissue: Steinert's disease, Lyme disease, Chagas' disease with heart involvement or hypothyroidism.

The selection of patients and controls are done through a sampling of consecutive patients seen in our outpatient rheumatology center to achieve the sample size. This has been fixed in two subgroups: 100 patients with SLE and positive for anti-Ro (with positivity for anti-Ro only 52 or positivity for anti-Ro and anti-Ro 52 60) and 50 patients (controls ) with SLE and negative for anti-Ro (anti-Ro52 and anti-Ro 60).

As defined as primary variables, the study of cardiac conduction disorders will be done through the analysis of resting electrocardiogram (ECG) and a 24-hour Holter.

Other descriptive variables are listed below:

• Collection of general medical history of patients, with emphasis on Rheumatology and cardiac involvement.

• Check the current medication.

• Height and weight.

• Physical examination.

• 12-lead resting ECG with analysis of rate base, as well as the duration of the PR interval, QRS and QT. Analysis of the presence of intraventricular conduction disorders and the presence of ectopic beats.

• Record 24-hour Holter Presence and number of ventricular ectopic beats, classification of events according to the Lown's criteria. Presence of significant pauses (RR interval> 2000mseg). Measurement of corrected QT (QTc).

• Presence of autonomic dysfunction parameters: time domain parameters such as the mean RR interval, standard deviation of all normal RR intervals (SDNN), the root of the mean difference between successive adjacent normal RR intervals (RMSSD ) and the percentage of adjacent intervals over 50mseg (PNN50)

• Echocardiography to rule out structural heart disease: Analysis of ventricular diameters and systolic and diastolic function, presence of significant valve disease, pulmonary systolic pressure, pericardial effusion and other congenital or acquired structural heart disease.

• Analysis with serologic immune profile, determining the degree of organic involvement by SLE

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: April 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrioventricular Block
• Death, Sudden
• Lupus Erythematosus, Systemic
• Sudden Death

Intervention

Other:
• No intervention
Observational

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol University Hospital	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Edwards CS, Mootoo R, Bhanji A. High grade heart block in association with SLE. Ann Rheum Dis. 2004 May;63(5):606. — View Citation

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. Erratum in: J Rheumatol 2001 May;28(5):1200. — View Citation

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. — View Citation

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. Epub 2005 Dec 9. Review. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. — View Citation

Santos-Pardo I, Martínez-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. — View Citation

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. Review. — View Citation

Villuendas R, Olivé A, Juncà G, Salvador I, Martínez-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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	QT and Corrected QT Intervals	Ventricular repolarization will be evaluated by 12-lead ECG recordings an 24-hour Holter recordings. Measurements will include QT and corrected QT intervals, and the presence of ventricular arrhythmia. Corrected QT (QTc) intervals will be obtained by measuring the QT interval (QTm) and the previous RR interval, following the Bazett formula (QTc=QTm divided by the square root of previous RR interval in seconds). A comparison will be made between the anti-Ro60 antibody positive patients and the anti-Ro60 antibody negative patients.	24 hours