Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Systemic Lupus Erythematous and Heart Conduction Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162992
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : October 28, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Roger Villuendas Sabaté, Germans Trias i Pujol Hospital

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Conditions Lupus Erythematosus, Systemic
Atrioventricular Block
Sudden Death
Intervention Other: No intervention
Enrollment 151
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SLE and Anti-Ro Antibodies Group SLE Without Anti-Ro Antibodies Group
Hide Arm/Group Description

Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)

No intervention: Observational

Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)

No intervention: Observational

Period Title: Overall Study
Started 51 100
Completed 46 99
Not Completed 5 1
Arm/Group Title SLE and Anti-Ro Antibodies Group SLE Without Anti-Ro Antibodies Group Total
Hide Arm/Group Description

Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)

No intervention: Observational

Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)

No intervention: Observational

Total of all reporting groups
Overall Number of Baseline Participants 46 99 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 99 participants 145 participants
44.14  (11.75) 45.24  (12.81) 44.49  (12.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 99 participants 145 participants
Female
42
  91.3%
91
  91.9%
133
  91.7%
Male
4
   8.7%
8
   8.1%
12
   8.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 46 participants 99 participants 145 participants
Caucasian
42
  91.3%
91
  91.9%
133
  91.7%
Latin-American
4
   8.7%
6
   6.1%
10
   6.9%
North-African
0
   0.0%
2
   2.0%
2
   1.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 46 participants 99 participants 145 participants
46 99 145
1.Primary Outcome
Title Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile
Hide Description Conduction disorders will be evaluated by 12-lead ECG recordings an 24-hour Holter recordings. Measurements will include PR intervals (in msec), QRS duration (in msec) .
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SLE and Anti-Ro Antibodies Group SLE Without Anti-Ro Antibodies Group
Hide Arm/Group Description:

Patients with SLE visited in the rheumatology outpatient's area with positivity to Anti-Ro antibodies. No intervention (only observational)

No intervention: Observational

Patients with SLE visited in the rheumatology outpatient's area with negativity to Anti-Ro antibodies. No intervention (only observational)

No intervention: Observational

Overall Number of Participants Analyzed 46 99
Mean (Standard Deviation)
Unit of Measure: msec
QRS duration 89.22  (8.5) 91.41  (8.9)
PR duration 145.68  (21.1) 146.72  (18.4)
2.Secondary Outcome
Title QT and Corrected QT Intervals
Hide Description Ventricular repolarization will be evaluated by 12-lead ECG recordings an 24-hour Holter recordings. Measurements will include QT and corrected QT intervals, and the presence of ventricular arrhythmia. Corrected QT (QTc) intervals will be obtained by measuring the QT interval (QTm) and the previous RR interval, following the Bazett formula (QTc=QTm divided by the square root of previous RR interval in seconds). A comparison will be made between the anti-Ro60 antibody positive patients and the anti-Ro60 antibody negative patients.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SLE and Anti-Ro Antibodies Group SLE Without Anti-Ro Antibodies Group
Hide Arm/Group Description:

Patients with SLE visited in the rheumatology outpatient's area with positivity to Anti-Ro antibodies. No intervention (only observational)

No intervention: Observational

Patients with SLE visited in the rheumatology outpatient's area with negativity to Anti-Ro antibodies. No intervention (only observational)

No intervention: Observational

Overall Number of Participants Analyzed 46 99
Mean (Standard Deviation)
Unit of Measure: msec
Corrected QT 420.74  (24.3) 421.33  (22.1)
QT dispersion 8.25  (7.8) 6.81  (5.9)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SLE and Anti-Ro Antibodies Group SLE Without Anti-Ro Antibodies Group
Hide Arm/Group Description

Patients with SLE visited in the rheumatology outpatient's area with positivity to Anti-Ro antibodies. No intervention (only observational)

No intervention: Observational

Patients with SLE visited in the rheumatology outpatient's area with negativity to Anti-Ro antibodies. No intervention (only observational)

No intervention: Observational

All-Cause Mortality
SLE and Anti-Ro Antibodies Group SLE Without Anti-Ro Antibodies Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/99 (0.00%) 
Hide Serious Adverse Events
SLE and Anti-Ro Antibodies Group SLE Without Anti-Ro Antibodies Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/99 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SLE and Anti-Ro Antibodies Group SLE Without Anti-Ro Antibodies Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/99 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Roger Villuendas
Organization: H. Germans Trias i Pujol
Phone: +34 4978398
EMail: rogervilluendas@hotmail.com
Publications:
Layout table for additonal information
Responsible Party: Roger Villuendas Sabaté, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT02162992    
Other Study ID Numbers: ICOR-2014-01
First Submitted: April 24, 2014
First Posted: June 13, 2014
Results First Submitted: September 4, 2019
Results First Posted: October 28, 2019
Last Update Posted: October 28, 2019