QT Dispersion in Patients With Systemic Lupus Erythematosus (SLE)

SLE Clinical Trial

Official title:

QT Dispersion in Patients With Systemic Lupus Erythematosus: the Impact of Disease Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031797
• Other study ID #: 86-1256
• Status: Completed
• Phase: N/A
• First received: December 12, 2009
• Last updated: December 12, 2009
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2007
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran:NIH
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• SLE

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QT dispersion			No