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QT Dispersion in Patients With Systemic Lupus Erythematosus (SLE)

NCT ID: NCT01031797

Last Updated: 2009-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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).

Conditions

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SLE

Keywords

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SLE Disease activity score QT dispersion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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High SLEDAS

High SLE disease activity score

No interventions assigned to this group

Low SLEDAS

SLE patient with low score

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shiraz University of medical sciences

Locations

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Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Site Status

Countries

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Iran

References

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Kojuri J, Nazarinia MA, Ghahartars M, Mahmoody Y, Rezaian Gr, Liaghat L. QT dispersion in patients with systemic lupus erythematosus: the impact of disease activity. BMC Cardiovasc Disord. 2012 Feb 27;12:11. doi: 10.1186/1471-2261-12-11.

Reference Type DERIVED
PMID: 22369270 (View on PubMed)

Other Identifiers

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86-1256

Identifier Type: -

Identifier Source: org_study_id