Systemic Lupus Erythematous and Heart Conduction Disorders

• ClinicalTrials.gov Identifier: NCT02162992
• Recruitment Status: Completed
• First Posted: June 13, 2014
• Results First Posted: October 28, 2019
• Last Update Posted: October 28, 2019
• Sponsor: Germans Trias i Pujol Hospital
• Information provided by (Responsible Party): Roger Villuendas Sabaté, Germans Trias i Pujol Hospital

• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Conditions: Lupus Erythematosus, Systemic; Atrioventricular Block; Sudden Death
• Intervention: Other: No intervention
• Enrollment: 151

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	SLE and Anti-Ro Antibodies Group	SLE Without Anti-Ro Antibodies Group
Arm/Group Description	Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) No intervention: Observational	Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) No intervention: Observational
Period Title: Overall Study
Started	51	100
Completed	46	99
Not Completed	5	1

Baseline Characteristics

Arm/Group Title		SLE and Anti-Ro Antibodies Group	SLE Without Anti-Ro Antibodies Group	Total
Arm/Group Description		Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) No intervention: Observational	Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) No intervention: Observational	Total of all reporting groups
Overall Number of Baseline Participants		46	99	145
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	46 participants	99 participants	145 participants
		44.14 (11.75)	45.24 (12.81)	44.49 (12.06)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	46 participants	99 participants	145 participants
	Female	42 91.3%	91 91.9%	133 91.7%
	Male	4 8.7%	8 8.1%	12 8.3%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Ethnicity	Number Analyzed	46 participants	99 participants	145 participants
	Caucasian	42 91.3%	91 91.9%	133 91.7%
	Latin-American	4 8.7%	6 6.1%	10 6.9%
	North-African	0 0.0%	2 2.0%	2 1.4%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Spain	Number Analyzed	46 participants	99 participants	145 participants
		46	99	145

Outcome Measures

1. Primary Outcome

Title	Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile
Description	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) .
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SLE and Anti-Ro Antibodies Group	SLE Without Anti-Ro Antibodies Group
Arm/Group Description:	Patients with SLE visited in the rheumatology outpatient's area with positivity to Anti-Ro antibodies. No intervention (only observational) No intervention: Observational	Patients with SLE visited in the rheumatology outpatient's area with negativity to Anti-Ro antibodies. No intervention (only observational) No intervention: Observational
Overall Number of Participants Analyzed	46	99
Mean (Standard Deviation); Unit of Measure: msec
QRS duration	89.22 (8.5)	91.41 (8.9)
PR duration	145.68 (21.1)	146.72 (18.4)

2. Secondary Outcome

Title	QT and Corrected QT Intervals
Description	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.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SLE and Anti-Ro Antibodies Group	SLE Without Anti-Ro Antibodies Group
Arm/Group Description:	Patients with SLE visited in the rheumatology outpatient's area with positivity to Anti-Ro antibodies. No intervention (only observational) No intervention: Observational	Patients with SLE visited in the rheumatology outpatient's area with negativity to Anti-Ro antibodies. No intervention (only observational) No intervention: Observational
Overall Number of Participants Analyzed	46	99
Mean (Standard Deviation); Unit of Measure: msec
Corrected QT	420.74 (24.3)	421.33 (22.1)
QT dispersion	8.25 (7.8)	6.81 (5.9)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	SLE and Anti-Ro Antibodies Group	SLE Without Anti-Ro Antibodies Group
Arm/Group Description	Patients with SLE visited in the rheumatology outpatient's area with positivity to Anti-Ro antibodies. No intervention (only observational) No intervention: Observational	Patients with SLE visited in the rheumatology outpatient's area with negativity to Anti-Ro antibodies. No intervention (only observational) No intervention: Observational
All-Cause Mortality
	SLE and Anti-Ro Antibodies Group	SLE Without Anti-Ro Antibodies Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/46 (0.00%)	0/99 (0.00%)
Serious Adverse Events
	SLE and Anti-Ro Antibodies Group	SLE Without Anti-Ro Antibodies Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/46 (0.00%)	0/99 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	SLE and Anti-Ro Antibodies Group	SLE Without Anti-Ro Antibodies Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/46 (0.00%)	0/99 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Roger Villuendas
• Organization: H. Germans Trias i Pujol
• Phone: +34 4978398
• EMail: rogervilluendas@hotmail.com

Publications:

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.

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.

Seferović PM, Ristić AD, Maksimović R, Simeunović DS, Ristić GG, Radovanović G, Seferović 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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: Roger Villuendas Sabaté, Germans Trias i Pujol Hospital
• ClinicalTrials.gov Identifier: NCT02162992
• Other Study ID Numbers: ICOR-2014-01
• First Submitted: April 24, 2014
• First Posted: June 13, 2014
• Results First Submitted: September 4, 2019
• Results First Posted: October 28, 2019
• Last Update Posted: October 28, 2019