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Increased Heart Rhythm in Response to High-dose Intravenous Methylprednisolone Pulse Therapy of Moderate-to-severe Graves' Orbitopathy
Sponsor study identifier
observational
40
0 countries
N/A
Study Start
January 1, 2011
Actual (reported)Primary Completion
February 20, 2020
Actual (reported)Study Completion
February 20, 2020
Actual (reported)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 6x0.5g followed by 6x0.25g every week).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 20, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2011
Actual (reported)February 20, 2020
Actual (reported)February 20, 2020
Actual (reported)May 5, 2020
Actual (reported)May 18, 2020
Actual (reported)24-hour Holter ECG Monitoring - 1st pulse mean HR
Analysis of changes in mean HR between day before and day of 1st pulse of IVMP, day of 1st IVMP and day after 1st IVMP, day before and day after 1st IVMP
72 hours
24-hour Holter ECG Monitoring - 6th pulse mean HR
Analysis of changes in mean HR between day before and day of 6th pulse of IVMP, day of 6th IVMP and day after 6th IVMP, day before and day after 6th IVMP
72 hours
24-hour Holter ECG Monitoring - 12th mean HR
Analysis of changes in mean HR between day before and day of 12th pulse of IVMP, day of 12th IVMP and day after 12th IVMP, day before and day after 12th IVMP
72 hours
Each participant received IVMP according to EUGOGO recommendations (cumulative dose of methylprednisolone 4.5 g, treatment duration 12 weeks in single weekly intravenous pulses, first 6 weeks 0.5g of IVMP, next 6 weeks 0.25g of IVMP).
Patients admitted to the clinic for routine treatment of active, moderate-to-severe GO
All assays were performed in sera obtained from venous blood samples and analysed immediately after blood sampling in The Endocrinology Research Laboratory in the hospital. All samples were centrifugated for plasma immediately after delivery (15 min; 1000 xg) and separated for both categories (EDTA and heparin) - 2 x 400 ul for test tubes with protease inhibitors and 4 x 500 ul with no additives. Then all assays were frozen immediately to -70°C.
40 participants (actual enrollment reported by the registry).
First Submitted
May 5, 2020
First Posted
May 18, 2020
Study Start
January 1, 2011
Actual (reported)Serum potassium levels Day 0 - Day 1
48 hours
Serum epinephrine levels Day 0 - Day 1
48 hours
Serum norepinephrine levels Day 0 - Day 1
48 hours
Urine potassium levels Day 0
24 hours
72-hour ambulatory blood pressure monitoring (ABPM) - 1st pulse mean BP
72 hours
Serum potassium levels Day 0 - Day 7
7 days
Serum potassium levels Day 0 - Day 2
72 hours
Serum epinephrine levels Day 0 - Day 7
7 days
Contact the study team to confirm eligibility.
Primary Completion
February 20, 2020
Actual (reported)Study Completion
February 20, 2020
Actual (reported)Last Updated
May 18, 2020
Record last verified: 2020-05
The collected data will be shared in a publication. It includes all laboratory results from all points of evaluation, results of 72-hour Holter ECG and 72-hour ABPM.
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Source: ClinicalTrials.gov.
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