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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLE and Anti-Ro antibodies Group | Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) |
| |
| SLE without Anti-Ro antibodies Group | Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion 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:
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Patients with SLE visited in the rheumatology outpatient's area.
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| Name | Affiliation | Role |
|---|---|---|
| Roger Villuendas | GTIPUH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias i Pujol University Hospital | Badalona | Barcelona | 08916 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20696018 | Background | 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. | |
| 917056 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SLE and Anti-Ro Antibodies Group | Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) No intervention: Observational |
| FG001 | SLE Without Anti-Ro Antibodies Group | Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) No intervention: Observational |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SLE and Anti-Ro Antibodies Group | Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) No intervention: Observational |
| BG001 | SLE Without Anti-Ro Antibodies Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) . | Posted | Mean | Standard Deviation | msec | 24 hours |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SLE and Anti-Ro Antibodies Group | Patients with SLE visited in the rheumatology outpatient's area with positivity to Anti-Ro antibodies. No intervention (only observational) No intervention: Observational |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roger Villuendas | H. Germans Trias i Pujol | +34 4978398 | rogervilluendas@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 22, 2016 | Oct 4, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D054537 | Atrioventricular Block |
| D003645 | Death, Sudden |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| 24 hours |
| 16980722 | 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. |
| 15082501 | 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. |
| 16218462 | 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. |
| 23758256 | 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. |
| 3493020 | 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. |
| 2396870 | 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. |
| 8403587 | 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. |
| 16234186 | 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. |
| 18604183 | 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. |
| 16782554 | 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. |
| 21739618 | 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. |
| 24486277 | 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. |
| 11246679 | 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. |
| 34192953 | Derived | 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. |
Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)
No intervention: Observational
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | msec | 24 hours |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | SLE Without Anti-Ro Antibodies Group | Patients with SLE visited in the rheumatology outpatient's area with negativity to Anti-Ro antibodies. No intervention (only observational) No intervention: Observational | 0 | 99 | 0 | 99 | 0 | 99 |
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| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003643 | Death |