Ignite Creation Date:
2024-05-06 @ 2:41 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04391439
Status:
COMPLETED
Last Update Posted:
2020-05-18
First Post:
2020-05-05
Brief Title:
Heart Rhythm After Intravenous Methylprednisolone Administration
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
Increased Heart Rhythm in Response to High-dose Intravenous Methylprednisolone Pulse Therapy of Moderate-to-severe Graves Orbitopathy
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
High doses of intravenous iv glucocorticoids GCs are commonly used as a treatment for many autoimmune and inflammatory disorders According to the European Group on Graves Orbitopathy EUGOGO guidelines intravenous methylprednisolone IVMP is an accepted first-line agent for active moderate-to-severe and very severe Graves orbitopathy GO This treatment is proven to be more efficient and safer than oral GCs However some patients may experience adverse cardiovascular effects during the administration of iv GCs which in rare cases may even be fatal There are limited data mostly obtained from case reports reporting the occurrence of cardiac arrhythmias acute myocardial infarction or heart failure Increased heart rhythm HR has drawn attention of researchers as a possible adverse effect correlated with IVMP During this study investigators performed 72-hours of Holter ECG and ambulatory blood pressure monitoring ABPM to evaluate the impact of IVMP on patients with moderate-to-severe GO concerning HR and blood pressure BP changes In order to elucidate possible mechanism of observed changes researchers investigated the level of potassium in serum and urine and catecholamines epinephrine norepinephrine in serum All patients were treated routinely according to EUGOGO recommendations with standard doses of methylprednisolone with standard recommended schedule Inclusion criterion for the therapy was according to EUGOGO guidelines active moderate-to-severe and active GO 12 pulses of IVMP 6x05g followed by 6x025g every week
Detailed Description:
The clinical status of patients was evaluated before each pulse including blood pressure monitoring glucose level monitoring and symptoms of infection HR and BP was measured continuously for 3 consecutive days the day before the day of IVMP and the day after IVMP during 1st 6th and 12th IVMP pulse using 24-hour Holter ECG and ABMP Serum laboratory tests for potassium epinephrine and norepinephrine were measured 3 times the day before and the day of first IVMP pulse and 1 time the second and sixth day after 1st IVMP Additionally urine samples for potassium were collected 5 times the day of first IVMP pulse and 1 time the second and sixth day after 1st IVMP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None