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Systemic Lupus Erythematous and Heart Conduction Disorders

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02162992
Enrollment
151
Registered
2014-06-13
Start date
2014-04-30
Completion date
2018-04-30
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrioventricular Block, Lupus Erythematosus, Systemic, Sudden Death

Keywords

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

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.

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

Interventions

OTHERNo intervention

Observational

Sponsors

Germans Trias i Pujol Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile24 hoursConduction 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) .

Secondary

MeasureTime frameDescription
QT and Corrected QT Intervals24 hoursVentricular 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.

Countries

Spain

Participant flow

Participants by arm

ArmCount
SLE and Anti-Ro Antibodies Group
Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) No intervention: Observational
46
SLE Without Anti-Ro Antibodies Group
Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational) No intervention: Observational
99
Total145

Baseline characteristics

CharacteristicSLE and Anti-Ro Antibodies GroupSLE Without Anti-Ro Antibodies GroupTotal
Age, Continuous44.14 years
STANDARD_DEVIATION 11.75
45.24 years
STANDARD_DEVIATION 12.81
44.49 years
STANDARD_DEVIATION 12.06
Race/Ethnicity, Customized
Ethnicity
Caucasian
42 Participants91 Participants133 Participants
Race/Ethnicity, Customized
Ethnicity
Latin-American
4 Participants6 Participants10 Participants
Race/Ethnicity, Customized
Ethnicity
North-African
0 Participants2 Participants2 Participants
Region of Enrollment
Spain
46 participants99 participants145 participants
Sex: Female, Male
Female
42 Participants91 Participants133 Participants
Sex: Female, Male
Male
4 Participants8 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 460 / 99
other
Total, other adverse events
0 / 460 / 99
serious
Total, serious adverse events
0 / 460 / 99

Outcome results

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) .

Time frame: 24 hours

ArmMeasureGroupValue (MEAN)Dispersion
SLE and Anti-Ro Antibodies GroupPresence of Conduction Disorders in Patients With SLE Regarding to Its Serologic ProfileQRS duration89.22 msecStandard Deviation 8.5
SLE and Anti-Ro Antibodies GroupPresence of Conduction Disorders in Patients With SLE Regarding to Its Serologic ProfilePR duration145.68 msecStandard Deviation 21.1
SLE Without Anti-Ro Antibodies GroupPresence of Conduction Disorders in Patients With SLE Regarding to Its Serologic ProfileQRS duration91.41 msecStandard Deviation 8.9
SLE Without Anti-Ro Antibodies GroupPresence of Conduction Disorders in Patients With SLE Regarding to Its Serologic ProfilePR duration146.72 msecStandard Deviation 18.4
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.

Time frame: 24 hours

ArmMeasureGroupValue (MEAN)Dispersion
SLE and Anti-Ro Antibodies GroupQT and Corrected QT IntervalsCorrected QT420.74 msecStandard Deviation 24.3
SLE and Anti-Ro Antibodies GroupQT and Corrected QT IntervalsQT dispersion8.25 msecStandard Deviation 7.8
SLE Without Anti-Ro Antibodies GroupQT and Corrected QT IntervalsCorrected QT421.33 msecStandard Deviation 22.1
SLE Without Anti-Ro Antibodies GroupQT and Corrected QT IntervalsQT dispersion6.81 msecStandard Deviation 5.9

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026