An observational study in Lupus Erythematosus, Systemic, Atrioventricular Block and Sudden Death, sponsored by Germans Trias i Pujol Hospital. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-28.
Sponsored by Germans Trias i Pujol Hospital · Observational
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:
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's enrollment of 151 is close to the median of 151 across 280 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Germans Trias i Pujol Hospital is the lead sponsor of 89 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with SLE visited in the rheumatology outpatient's area.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Clinical history of other conditions that affect heart conduction:
Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)
Other: No intervention
Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)
Other: No intervention
Observational
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
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
| Milestone | SLE and Anti-Ro Antibodies Group | SLE Without Anti-Ro Antibodies Group |
|---|---|---|
| Started | 51 | 100 |
| Completed | 46 | 99 |
| Not completed | 5 | 1 |
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) .
| msec | SLE and Anti-Ro Antibodies Group | SLE Without Anti-Ro Antibodies Group |
|---|---|---|
| QRS duration | 89.22 ± 8.5 | 91.41 ± 8.9 |
| PR duration | 145.68 ± 21.1 | 146.72 ± 18.4 |
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.
| msec | SLE and Anti-Ro Antibodies Group | SLE Without Anti-Ro Antibodies Group |
|---|---|---|
| Corrected QT | 420.74 ± 24.3 | 421.33 ± 22.1 |
| QT dispersion | 8.25 ± 7.8 | 6.81 ± 5.9 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SLE and Anti-Ro Antibodies Group | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| SLE Without Anti-Ro Antibodies Group | 0/99 (0%) | 0/99 (0%) | 0/99 (0%) |
| Age, Continuous(years) | SLE and Anti-Ro Antibodies Group | SLE Without Anti-Ro Antibodies Group | Total |
|---|---|---|---|
| Mean | 44.14 ± 11.75 | 45.24 ± 12.81 | 44.49 ± 12.06 |
| Sex: Female, Male(Participants) | SLE and Anti-Ro Antibodies Group | SLE Without Anti-Ro Antibodies Group | Total |
|---|---|---|---|
| Female | 42 | 91 | 133 |
| Male | 4 | 8 | 12 |
| Race/Ethnicity, Customized(Participants) | SLE and Anti-Ro Antibodies Group | SLE Without Anti-Ro Antibodies Group | Total |
|---|---|---|---|
| Ethnicity — Caucasian | 42 | 91 | 133 |
| Ethnicity — Latin-American | 4 | 6 | 10 |
| Ethnicity — North-African | 0 | 2 | 2 |
| Region of Enrollment(participants) | SLE and Anti-Ro Antibodies Group | SLE Without Anti-Ro Antibodies Group | Total |
|---|---|---|---|
| Spain | 46 | 99 | 145 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lupus Erythematosus, Systemic →
Germans Trias i Pujol Hospital