Trial Outcomes & Findings for Systemic Lupus Erythematous and Heart Conduction Disorders (NCT NCT02162992)
NCT ID: NCT02162992
Last Updated: 2019-10-28
Results Overview
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) .
COMPLETED
151 participants
24 hours
2019-10-28
Participant Flow
Participant milestones
| Measure |
SLE and Anti-Ro Antibodies Group
Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)
No intervention: Observational
|
SLE Without Anti-Ro Antibodies Group
Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)
No intervention: Observational
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
100
|
|
Overall Study
COMPLETED
|
46
|
99
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Systemic Lupus Erythematous and Heart Conduction Disorders
Baseline characteristics by cohort
| Measure |
SLE and Anti-Ro Antibodies Group
n=46 Participants
Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)
No intervention: Observational
|
SLE Without Anti-Ro Antibodies Group
n=99 Participants
Patients with SLE visited in the rheumatology outpatient's area. No intervention (only observational)
No intervention: Observational
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.14 years
STANDARD_DEVIATION 11.75 • n=99 Participants
|
45.24 years
STANDARD_DEVIATION 12.81 • n=107 Participants
|
44.49 years
STANDARD_DEVIATION 12.06 • n=206 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian
|
42 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Latin-American
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · North-African
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
46 participants
n=99 Participants
|
99 participants
n=107 Participants
|
145 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hoursConduction 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) .
Outcome measures
| Measure |
SLE and Anti-Ro Antibodies Group
n=46 Participants
Patients with SLE visited in the rheumatology outpatient's area with positivity to Anti-Ro antibodies. No intervention (only observational)
No intervention: Observational
|
SLE Without Anti-Ro Antibodies Group
n=99 Participants
Patients with SLE visited in the rheumatology outpatient's area with negativity to Anti-Ro antibodies. No intervention (only observational)
No intervention: Observational
|
|---|---|---|
|
Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile
QRS duration
|
89.22 msec
Standard Deviation 8.5
|
91.41 msec
Standard Deviation 8.9
|
|
Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile
PR duration
|
145.68 msec
Standard Deviation 21.1
|
146.72 msec
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: 24 hoursVentricular 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.
Outcome measures
| Measure |
SLE and Anti-Ro Antibodies Group
n=46 Participants
Patients with SLE visited in the rheumatology outpatient's area with positivity to Anti-Ro antibodies. No intervention (only observational)
No intervention: Observational
|
SLE Without Anti-Ro Antibodies Group
n=99 Participants
Patients with SLE visited in the rheumatology outpatient's area with negativity to Anti-Ro antibodies. No intervention (only observational)
No intervention: Observational
|
|---|---|---|
|
QT and Corrected QT Intervals
Corrected QT
|
420.74 msec
Standard Deviation 24.3
|
421.33 msec
Standard Deviation 22.1
|
|
QT and Corrected QT Intervals
QT dispersion
|
8.25 msec
Standard Deviation 7.8
|
6.81 msec
Standard Deviation 5.9
|
Adverse Events
SLE and Anti-Ro Antibodies Group
SLE Without Anti-Ro Antibodies Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place