Impact of Intravenous Methylprednisolone Treatment on Blood Pressure

NCT ID: NCT03590080

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2015-12-30

Brief 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).

Detailed 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.

Conditions

Graves Disease; Graves Ophthalmopathy; Hypertension; Blood Pressure; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

active, moderate-to-severe GO

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).

Methylprednisolone

Intervention Type: DRUG

Interventions

Methylprednisolone

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Piotr Miskiewicz

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piotr Miśkiewicz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology Medical University of Warsaw

Other Identifiers

IVMPHeart

Identifier Type: -

Identifier Source: org_study_id