Impact of Intravenous Methylprednisolone Treatment on Blood Pressure

Hypertension Clinical Trial

Official title:

Blood Pressure Profile and NT-proBNP Dynamics in Response to Intravenous Methylprednisolone Pulse Therapy of Severe Graves' Orbitopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590080
• Other study ID #: IVMPHeart
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: December 30, 2015

Study information

• Verified date: July 2018
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

Laboratory tests such as NT-proBNP, troponin I (TnI) and high - sensitivity C - reactive protein (hs-CRP) were performed before, 24 h and 48 h after IVMP during the following pulses: 1st, 6th and 12th. Patients underwent echocardiographic examination before 1st and after 12th pulse. 48-hours ambulatory blood pressure monitoring (ABPM) (for 24 hours before and 24 hours after IVMP) was done during the following pulses: 1st, 6th and 12th.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 30, 2015
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• active, moderate-to-severe GO according to EUGOGO classification

• euthyroidism

• completion of at least first six IVMP pulses.

Exclusion Criteria:

• cardiovascular morbidity (such as chronic heart failure and/or coronary heart disease)

• uncontrolled hypertension (defined as systolic blood pressure (SBP) more than 140 mmHg and/or diastolic blood pressure (DBP) more than 90 mmHg)

• contraindications to IVMP therapy

• previous GCs treatment in the last 6 months.

Related Conditions & MeSH terms

• Blood Pressure
• Eye Diseases
• Graves Disease
• Graves Ophthalmopathy
• Heart Failure
• Hypertension

Intervention

Drug:
• Methylprednisolone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	hs-CRP	Change in value of hs-CRP from baseline (before administration of methylprednisolone) to 24 hours after first intravenous pulse	24 hours
Secondary	Biomarker of cardiomyocyte injury - TnI	Change in value of TnI from baseline (before administration of methylprednisolone) to 24 hours after first intravenous pulse	24 hours
Secondary	NT-proBNP 1-48h	Change in value of NT-proBNP from baseline (before administration of methylprednisolone) to 48 hours after first intravenous pulse	48 hours