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Systemic Lupus Erythematous and Heart Conduction Disorders

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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

Tracking Information
First Submitted Date April 24, 2014
First Posted Date June 13, 2014
Results First Submitted Date September 4, 2019
Results First Posted Date October 28, 2019
Last Update Posted Date October 28, 2019
Study Start Date April 2014
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2019)
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) .
Original Primary Outcome Measures
 (submitted: June 12, 2014)
Incidence of conduction disorders in patients with SLE regarding to its serologic profile [ Time Frame: One year ]
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) and the presence of second or third degree atrioventricular blockade.
Change History
Current Secondary Outcome Measures
 (submitted: October 4, 2019)
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.
Original Secondary Outcome Measures
 (submitted: June 12, 2014)
Association between anti-Ro60 antibody and conduction disturbances such as QT interval prolongation. [ 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. A comparison will be made between the anti-Ro60 antibody positive patients and the anti-Ro60 antibody negative patients.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Systemic Lupus Erythematous and Heart Conduction Disorders
Official Title Repolarization Disorders and Heart Conduction Disorders in Patients With Systemic Lupus Erythematous
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
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with SLE visited in the rheumatology outpatient's area.
Condition
  • Lupus Erythematosus, Systemic
  • Atrioventricular Block
  • Sudden Death
Intervention Other: No intervention
Observational
Study Groups/Cohorts
  • SLE and Anti-Ro antibodies Group
    Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)
    Intervention: Other: No intervention
  • SLE without Anti-Ro antibodies Group
    Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)
    Intervention: Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 4, 2019)
151
Original Estimated Enrollment
 (submitted: June 12, 2014)
86
Actual Study Completion Date April 2018
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02162992
Other Study ID Numbers ICOR-2014-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Roger Villuendas Sabaté, Germans Trias i Pujol Hospital
Study Sponsor Germans Trias i Pujol Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Roger Villuendas GTIPUH
PRS Account Germans Trias i Pujol Hospital
Verification Date October 2019