QT Dispersion in Patients With Systemic Lupus Erythematosus (SLE)

December 12, 2009 updated by: Shiraz University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
QT dispersion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

December 12, 2009

First Submitted That Met QC Criteria

December 12, 2009

First Posted (Estimate)

December 15, 2009

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 12, 2009

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86-1256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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