Blood Pressure Profile and NT-proBNP Dynamics in Response to Intravenous Methylprednisolone Pulse Therapy of Severe Graves' Orbitopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 主要终点
- 48-hour ambulatory blood pressure monitoring (ABPM)- 1 max systolic BP
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •active, moderate-to-severe GO according to EUGOGO classification
- •euthyroidism
- •completion of at least first six IVMP pulses.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
48-hour ambulatory blood pressure monitoring (ABPM)- 1 max systolic BP
时间窗: 48 hours
Analysis of changes in maximal systolic blood pressure in ABPM between day before methylprednisolone administration and second day after first pulse of methylprednisolone administration
NT-proBNP 1-12w
时间窗: 12 weeks
Change in value of NT-proBNP from baseline (before administration of methylprednisolone) to the basic NT-proBNP before last pulse with methylprednisolone
NT-proBNP 1-24h
时间窗: 24 hours
Change in value of NT-proBNP from baseline (before administration of methylprednisolone) to 24 hours after first intravenous pulse
48-hour ambulatory blood pressure monitoring (ABPM)- 1 mean BP
时间窗: 48 hours
Analysis of changes in mean blood pressure in ABPM between day before methylprednisolone administration and second day after first pulse of methylprednisolone administration
48-hour ambulatory blood pressure monitoring (ABPM)- 12 mean BP
时间窗: 12 weeks
Analysis of changes in mean blood pressure in ABPM between day before methylprednisolone administration and second day after 12th pulse of methylprednisolone administration
48-hour ambulatory blood pressure monitoring (ABPM)- 12 max systolic BP
时间窗: 48 hours
Analysis of changes in maximal systolic blood pressure in ABPM between day before methylprednisolone administration and second day after 12th pulse of methylprednisolone administration
echocardiographic examinations - median values of Ejection Fraction (EF)
时间窗: 12 weeks
Analysis of change in median values of EF between echocardiographic examinations before first methylprednisolone administration and after last pulse of methylprednisolone
次要结局
- hs-CRP(24 hours)
- NT-proBNP 1-48h(48 hours)
- Biomarker of cardiomyocyte injury - TnI(24 hours)
研究者
Piotr Miskiewicz
MD, PhD
Medical University of Warsaw
