QT Dispersion in Patients With Systemic Lupus Erythematosus (SLE)

Completed

• Conditions: SLE

• Registration Number: NCT01031797
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

QT dispersion can be a useful, simple noninvasive method for the early detection of cardiac involvement in SLE patients with active disease. The investigators therefore recommend cardiovascular evaluation for every SLE patient with an SLEDAI higher than 10.

Detailed Description

Objective: Patients with systemic lupus erythematosus (SLE) have increased cardiovascular morbidity and mortality. Although autopsy studies have documented that the heart is affected in most SLE patients, clinical manifestations occur in less than 10%. QT dispersion is a new parameter that can be used to assess homogeneity of cardiac repolarization and autonomic function. We compared the increase in QT dispersion in SLE patients with high disease activity and mild or moderate disease activity.

Methods: One hundred twenty-four patients with SLE were enrolled in the study. Complete history and physical exam, ECG, echocardiography, exercise test and SLE disease activity index (SLEDAI) were recorded. Twenty patients were excluded on the basis of our exclusion criteria. The patients were divided to two groups based on SLEDAI: 54 in the high-score group (SLEDAI \>10) and 50 in the low-score group (SLEDAI \<10).

Study Timeline

• Status Verified: 2007-07
• Study Start: 2008-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2009-12-12
• Study First Submitted QC: 2009-12-12
• Last Update Submitted: 2009-12-12
• Study First Posted: 2009-12-15
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• no administration of drugs that would potentially influence QT duration except hydroxychloroquine
• no history of ischemic heart disease, congestive heart failure, atrial fibrillation, bundle branch block or abnormal serum electrolytes
• normal resting ECG and a good-quality ECG recording to measure the QT interval.

Exclusion Criteria

• moderate or severe valve disease
• atrial fibrillation and other ECG abnormalities
• systolic left ventricular dysfunction (ejection fraction <50% or left ventricular end diastolic dimension >5.5 mm
• unreliable identification of the end of the T wave in the ECG and
• known presence of cardiac disease including hypertension, diabetes or coronary artery disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
QT dispersion

Trial Locations

Locations (1)

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of