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Blood Pressure Profile and NT-proBNP Dynamics in Response to Intravenous Methylprednisolone Pulse Therapy of Severe Graves' Orbitopathy
Sponsor study identifier
observational
32
0 countries
N/A
Study Start
January 1, 2011
Actual (reported)Primary Completion
December 30, 2015
Actual (reported)Study Completion
December 30, 2015
Actual (reported)Hypertension is common side effect of Cushing Syndrome (CS): in patients with endogenous CS and those treated with glucocorticosteroids (GCs). The impact of the intravenous GCs therapy on blood pressure (BP) remains unclear. According to the European Group On Graves' Orbitopathy (EUGOGO), patients with active, severely symptomatic and sight-threatening Graves' orbitopathy (GO) should be treated with high dose intravenous methylprednisolone (IVMP) pulses. There are, however, reports of fatal side effects that may be associated with this therapy (e.g.: pulmonary embolism, myocardial infarction, severe cerebrovascular events, acute liver damage and sudden death). For this reason, the cumulative dose of IVMP should not exceed 8 g within each treatment course, and pulses should not be given on consecutive or alternate days, except for the case of dysthyroid optic neuropathy. A consensus on the monitoring of patients during and after IVMP pulse administration is not yet established. What is more, there is lack of paper regarding pattern of blood pressure at various time points during and after ivGCs administration. Thus, the investigators decided to evaluate acute changes of N-terminal pro-brain natriuretic peptide (NT-proBNP) as a marker of hemodynamic stress and to monitor BP before, during and after IVMP pulse administration. All of 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.
December 30, 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2011
Actual (reported)December 30, 2015
Actual (reported)December 30, 2015
Actual (reported)June 30, 2018
Actual (reported)July 18, 2018
Actual (reported)NT-proBNP 1-24h
Change in value of NT-proBNP from baseline (before administration of methylprednisolone) to 24 hours after first intravenous pulse
24 hours
NT-proBNP 1-12w
Change in value of NT-proBNP from baseline (before administration of methylprednisolone) to the basic NT-proBNP before last pulse with methylprednisolone
12 weeks
48-hour ambulatory blood pressure monitoring (ABPM)- 1 mean BP
Analysis of changes in mean blood pressure in ABPM between day before methylprednisolone administration and second day after first pulse of methylprednisolone administration
48 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).
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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 Central Laboratory in the hospital. NT-proBNP was measured using a Flex® Reagent Cartridge and Dimension®EXLTM integrated chemistry system with a LOCI® Module (Siemens HealthCare Diagnostics Ltd., Camberley, UK). The cutoff value of NT - proBNP typical for hemodynamic stress in the left ventricle was defined as ≥125 pg/ml. Measurements of TnI and hs-CRP were made. Analysis of TnI was performed on Siemens Dimension System (ExL LOCI TnI assay). TnI values ≥ 0.056 ng/mL as above the 99th percentile were reported as positive. Measurement of hs-CRP was performed in serum using an immunoturbidimetric method on Cobas 6000 Analyzer (Roche Diagnostics).
Piotr Miśkiewicz, MD, PhD
Department of Endocrinology Medical University of Warsaw
32 participants (actual enrollment reported by the registry).
First Submitted
June 30, 2018
First Posted
July 18, 2018
Study Start
January 1, 2011
Actual (reported)48-hour ambulatory blood pressure monitoring (ABPM)- 12 mean BP
Analysis of changes in mean blood pressure in ABPM between day before methylprednisolone administration and second day after 12th pulse of methylprednisolone administration
12 weeks
48-hour ambulatory blood pressure monitoring (ABPM)- 1 max systolic BP
Analysis of changes in maximal systolic blood pressure in ABPM between day before methylprednisolone administration and second day after first pulse of methylprednisolone administration
48 hours
48-hour ambulatory blood pressure monitoring (ABPM)- 12 max systolic BP
Analysis of changes in maximal systolic blood pressure in ABPM between day before methylprednisolone administration and second day after 12th pulse of methylprednisolone administration
48 hours
echocardiographic examinations - median values of Ejection Fraction (EF)
Analysis of change in median values of EF between echocardiographic examinations before first methylprednisolone administration and after last pulse of methylprednisolone
12 weeks
hs-CRP
24 hours
Biomarker of cardiomyocyte injury - TnI
24 hours
NT-proBNP 1-48h
48 hours
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Primary Completion
December 30, 2015
Actual (reported)Study Completion
December 30, 2015
Actual (reported)Last Updated
July 18, 2018
Record last verified: 2018-07
The collected data will be shared in a publication. It includes all laboratory results from all points of evaluation, results of 48 - hour ABPM and echocardiographic measurements
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Source: ClinicalTrials.gov.
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