Clinical Trial: Systemic Lupus Erythematous and Heart Conduction Disorders

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary:

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:

  • C
    Sponsor: Germans Trias i Pujol Hospital

    Current Primary Outcome: 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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome: 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.


    Original Secondary Outcome: Same as current

    Information By: Germans Trias i Pujol Hospital

    Dates:
    Date Received: April 24, 2014
    Date Started: April 2014
    Date Completion: June 2016
    Last Updated: August 10, 2015
    Last Verified: August 2015