QT Dispersion in Patients With Systemic Lupus Erythematosus (SLE)

NCT01031797 | Completed DMC

• 1 other identifier: 86-1256
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

SLE

Keywords

SLE; Disease activity score; QT dispersion

Outcome Measures

Primary Outcomes (1)

• QT dispersion

Study Arms (2)

High SLEDAS

High SLE disease activity score

Low SLEDAS

SLE patient with low score

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

Related Publications (1)

• 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.

  PMID: 22369270 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2009
• First Posted: December 15, 2009
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 15, 2009

Record last verified: 2007-07

Locations

IR (1)