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Systemic Lupus Erythematous and Heart Conduction Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Roger Villuendas Sabaté, Germans Trias i Pujol Hospital

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.

Condition or disease Intervention/treatment
Lupus Erythematosus, Systemic Atrioventricular Block Sudden Death Other: No intervention

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

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Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Repolarization Disorders and Heart Conduction Disorders in Patients With Systemic Lupus Erythematous
Study Start Date : April 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : April 2018

Group/Cohort Intervention/treatment
SLE and Anti-Ro antibodies Group
Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)
Other: No intervention
Observational

SLE without Anti-Ro antibodies Group
Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)
Other: No intervention
Observational




Primary Outcome Measures :
  1. 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) .


Secondary Outcome Measures :
  1. QT and Corrected QT Intervals [ Time Frame: 24 hours ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with SLE visited in the rheumatology outpatient's area.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162992


Locations
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Spain
Germans Trias i Pujol University Hospital
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
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Principal Investigator: Roger Villuendas GTIPUH
  Study Documents (Full-Text)

Documents provided by Roger Villuendas Sabaté, Germans Trias i Pujol Hospital:
Publications:

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Responsible Party: Roger Villuendas Sabaté, Coordinator of the Electrophysiology and Cardiac Pacing Unit, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT02162992    
Other Study ID Numbers: ICOR-2014-01
First Posted: June 13, 2014    Key Record Dates
Results First Posted: October 28, 2019
Last Update Posted: October 28, 2019
Last Verified: October 2019
Keywords provided by Roger Villuendas Sabaté, Germans Trias i Pujol Hospital:
Antibodies, Antinuclear
SS-A antigen
Lupus Erythematosus, Systemic
Atrioventricular Block
Sudden death
Additional relevant MeSH terms:
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Atrioventricular Block
Cardiac Conduction System Disease
Lupus Erythematosus, Systemic
Death, Sudden
Death
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases