QT Dispersion in Patients With Systemic Lupus Erythematosus (SLE)

S

Shiraz University of Medical Sciences

Status

Completed

Conditions

SLE

Study type

Observational

Funder types

Other

Identifiers

NCT01031797
86-1256

Details and patient eligibility

About

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.

Full 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).

Enrollment

124 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

124 participants in 2 patient groups

High SLEDAS
Description:
High SLE disease activity score
Low SLEDAS
Description:
SLE patient with low score

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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