QT Dispersion in Patients With Systemic Lupus Erythematosus (SLE)

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01031797
First received: December 12, 2009
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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
SLE

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: QT Dispersion in Patients With Systemic Lupus Erythematosus: the Impact of Disease Activity

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • QT dispersion [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
High SLEDAS
High SLE disease activity score
Low SLEDAS
SLE patient with low score

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01031797

Locations
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

No publications provided by Shiraz University of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Javad Kojuri, Shiraz University of medical sciences
ClinicalTrials.gov Identifier: NCT01031797     History of Changes
Other Study ID Numbers: 86-1256
Study First Received: December 12, 2009
Last Updated: December 12, 2009
Health Authority: Iran:NIH

Keywords provided by Shiraz University of Medical Sciences:
SLE
Disease activity score
QT dispersion

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 20, 2014