Lupus Erythematosus, SystemicNCT02162992
Systemic Lupus Erythematous and Heart Conduction Disorders
An observational study of Lupus Erythematosus, Systemic and Atrioventricular Block, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic, Atrioventricular Block, Sudden Death
- How many people
- 151 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to Apr 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with SLE visited in the rheumatology outpatient's area.
Who may be able to join
- Patients with SLE diagnosis, according to SLE diagnostic criteria.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Germans Trias i Pujol University Hospital
Badalona, Barcelona, 08916
About this study
Official title: Repolarization Disorders and Heart Conduction Disorders in Patients With Systemic Lupus Erythematous
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.
Read the detailed 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
- Being tested
- No intervention
- Keywords
- Antibodies, Antinuclear, SS-A antigen, Lupus Erythematosus, Systemic, Atrioventricular Block, Sudden death
- Medical subject headings
- Lupus Erythematosus, Systemic, Atrioventricular Block, Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| SLE and Anti-Ro antibodies Group | Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) Receives: Other: No intervention | |
| SLE without Anti-Ro antibodies Group | Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Villuendas Sabaté, Germans Trias i Pujol Hospital
- Investigators
- Roger Villuendas, Principal investigator, GTIPUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162992
- Sponsor's protocol ID
- ICOR-2014-01
- Status last verified
- Oct 2019
- First submitted
- 24 Apr 2014
- Last updated
- 28 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 20696018Chameides 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.
PubMed 917056Seferovic 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.
PubMed 16980722Edwards 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.
PubMed 15082501Costedoat-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.
PubMed 16218462Santos-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.
PubMed 23758256Behan 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.
PubMed 3493020Logar 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.
PubMed 2396870O'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.
PubMed 8403587Lodde 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.
PubMed 16234186Costa 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.
PubMed 18604183Lazzerini 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.
PubMed 16782554Lazzerini 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.
PubMed 21739618Villuendas 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.
PubMed 24486277Gordon 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.
PubMed 11246679
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repolarization Disorders and Heart Conduction Disorders in Patients With Systemic Lupus Erythematous
- ClinicalTrials.gov ID
- NCT02162992
- Acronym / sponsor ID
- ICOR-2014-01
- Keywords
- Antibodies, Antinuclear, SS-A antigen, Lupus Erythematosus, Systemic, Atrioventricular Block, Sudden death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Posted 28 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE and Anti-Ro antibodies Group | – | Other: No interventionPatients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) |
| SLE without Anti-Ro antibodies Group | – | Other: No interventionPatients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with SLE visited in the rheumatology outpatient's area.
Key inclusion criteria (1 listed)
- Patients with SLE diagnosis, according to SLE diagnostic criteria.
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational | Other | SLE and Anti-Ro antibodies Group, SLE without Anti-Ro antibodies Group |
Primary outcome
Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile
Time frame: 24 hours
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) .
1 secondary outcome
QT and Corrected QT Intervals
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20696018Lazzerini 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.
- Background: PubMed 917056Chameides 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.
- Background: PubMed 16980722Seferovic 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.
- Background: PubMed 15082501Edwards 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.
- Background: PubMed 16218462Costedoat-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.
- Background: PubMed 23758256Santos-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.
- Background: PubMed 3493020Behan 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.
- Background: PubMed 2396870Logar 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.
- Background: PubMed 8403587O'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.
- Background: PubMed 16234186Lodde 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.
- Background: PubMed 18604183Costa 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.
- Background: PubMed 16782554Lazzerini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Villuendas principal investigator
GTIPUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic and Atrioventricular Block, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02162992, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019; AzTrials last refreshed its copy on 26 Oct 2026.