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QT Dispersion in Patients With Systemic Lupus Erythematosus (SLE)

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ClinicalTrials.gov Identifier: NCT01031797
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
Shiraz University of Medical Sciences

Study Description
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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.

Condition or disease
SLE

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 Design
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Study Type : Observational
Actual Enrollment : 124 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: QT Dispersion in Patients With Systemic Lupus Erythematosus: the Impact of Disease Activity
Study Start Date : January 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Groups and Cohorts
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Group/Cohort
High SLEDAS
High SLE disease activity score
Low SLEDAS
SLE patient with low score


Outcome Measures
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Primary Outcome Measures :
  1. QT dispersion

Eligibility Criteria
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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:   Probability Sample
Study Population
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).
Criteria

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.
Contacts and Locations
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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): NCT01031797


Locations
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Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Javad Kojuri, Shiraz University of medical sciences
ClinicalTrials.gov Identifier: NCT01031797    
Other Study ID Numbers: 86-1256
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: July 2007
Keywords provided by Shiraz University of Medical Sciences:
SLE
Disease activity score
QT dispersion
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases