An observational study in Corticosteroids Adverse Reaction, sponsored by Elza Abdessater. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Elza Abdessater · Observational
Among 51 studies in Arrhythmias, Cardiac with a site in Belgium — 10 open to participants now, 14 under way, none of them phase 3. Arrhythmias, Cardiac · Belgium.
Among the 51 studies in Arrhythmias, Cardiac with a site in Belgium, this one is the 20th largest by enrollment of the 20 observational ones, is one of 3 that started in 2018, is one of 20 observational ones, and was the 23rd registered.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's enrollment of 15 is below the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →10 of the 51 studies in Arrhythmias, Cardiac with a site in Belgium are open now, in 12 countries. Each count lists the studies.
Of the 167 Arrhythmias, Cardiac studies recruiting now, 118 (71%) set no upper age limit and 13 (8%) stop at 75 or younger; 31 take children under 18; 26 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →51 studies; the count open now beside each. This study's row is marked.
First in 1983; this study’s year is marked. 3 started in 2018.
Median enrollment 269 across the 31 interventional studies, 619 across the 20 observational. Of the 34 that completed or were terminated, 9 (26%) have results posted.
34 of 51 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Elza Abdessater as lead sponsor.
Elza Abdessater has 1 study filed under Arrhythmias, Cardiac — fewer than ten, so there is no comparison to draw.
2 of the studies in Arrhythmias, Cardiac with a site in Belgium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07118358Biotronik, Inc.BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System | 2027-03 |
| NCT07727057Biosense Webster, Inc.A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias | 2027-09-30 |
Among the 51 studies in Arrhythmias, Cardiac with a site in Belgium, from their registry updates:
The goal of this observational design is to study the effects of intravenous corticosteroids on heart rate variability, arrhythmias and microalbuminuria. Some previous studies have shown that intravenous corticosteroids could induce bradycardia but also supra-ventricular tachycardia and atrial fibrillation.
A second goal of this study is to investigate whether exogenous corticosteroids may induce microalbuminuria. A large retrospective study has revealed an association between microalbuminuria and corticosteroid use in the year preceding the measurement.
On intra-hospital patients, it will be explored the prevalence of arrythmias, the heart rate variability and the modification of the microalbuminuria level after intravenous infusion of corticosteroids. The investigator shall not initiate the treatment. Patients will receive high-dose intravenous corticosteroids for the treatment of different diseases. The departments, where the patients are enrolled, are: nephrology, neurology, dermatology and rheumatology and the day hospital. The day before the corticosteroids administration, a holter monitor will be started for at least 24h to detect arrhythmias and heart rate variations. By mean of a Finometer, beat-to-beat blood pressure, cardiac output and baroreflex sensitivity will be measured before, during and after the infusion. Blood and urine samples will be used to explore the effects of corticosteroids on microalbuminuria, electrolytes, CRP and glomerular filtration rate during the 3 days of observation.
To our knowledge, it will be the first prospective trial to explore a link between intravenous corticosteroids administration and heart rate variability, Baroreflex Sensitivity, as well as microalbuminuria.
Hospitalized patients who are starting high-dose corticotherapy in Hôpital Erasme (Brussels).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intravenous high dose corticosteroids
Also known as: Solumedrol
Arrhythmias
All types of arrhythmias (especially pauses and atrial fibrillation). Evaluated with a 72-hours Holter ECG monitoring
Time frame: Change between day 1 and day 3
Microalbuminuria
Microalbuminuria (mg/dL)
Time frame: Change in microalbuminuria (day 1 and day 3)
Microalbuminuria - Urinary Creatinine ratio
mg/g creatinine
Time frame: Change in microalbuminuria - urinary creatinine ratio (day 1 and day 3)
Baroreflex Sensitivity
Measured with a Finometer (ms/mmHg)
Time frame: Change in Baroreflex Sensitivity (day 1 and day 3)
Beat-to-beat blood pressure
Measured with a Finometer (mmHg)
Time frame: Change in beat-to-beat blood pressure (day 1 and day 3)
Heart Rate
Measured with a 72 hours Holter ECG monitoring (bpm)
Time frame: Change in Heart Rate (day 1 and day 3)
Standard Deviation of normal to normal R-R intervals (SDNN)
Measured with a 72 hours Holter ECG monitoring (ms)
Time frame: Change in SDNN (day 1 and day 3)
Root Mean Square of the Successive Differences (RMSSD)
Measured with a 72 hours Holter ECG monitoring (ms)
Time frame: Change in RMSSD (day 1 and day 3)
Mean number of times per hour in which the change in consecutive normal sinus R-R intervals exceeds 50 milliseconds (PNN50)
Measured with a 72 hours Holter ECG monitoring (%)
Time frame: Change in PNN50 (day 1 and day 3)
Low Frequency component of Heart Rate Variability (LF)
Measured with a 72 hours Holter ECG monitoring (ms\^2)
Time frame: Change in low frequencies (day 1 and day 3)
High Frequency component of Heart Rate Variability (HF)
Measured with a 72 hours Holter ECG monitoring (ms\^2)
Time frame: Change in high frequencies (day 1 and day 3)
Low to High Frequency Ratio of Heart Rate Variability (LF/HF)
Measured with a 72 hours Holter ECG monitoring
Time frame: Change in LF/HF (day 1 and day 3)
CRP
(mg/L)
Time frame: before and 1 to 3 days after the drug infusion
Glomerular Filtration Rate
CKD-EPI (mL/min/1.73m2)
Time frame: Before and 1 to 3 days after the drug infusion
Natremia
mmol/L
Time frame: Change in Natremia (day 1 and day 3)
Kaliemia
mmol/L
Time frame: Change in Kaliemia (day 1 and day 3)
Chloremia
mmol/L
Time frame: Change in Chloremia (day 1 and day 3)
Ran from Jan 2018 to primary completion in Jun 2018, 5 months.
Of 189 non-industry observational studies under Arrhythmias, Cardiac, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 140. This study's 5 months is below that.
Counting every sponsor, half of 258 studies reached it within 38 months; a quarter within 16 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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