The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension: Insights From Elastography Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- spleen stiffness measurement (SSM)
研究概览
简要总结
Carvedilol has emerged as the preferred non-selective β-blocker (NSBB) for treating portal hypertension. However, there is still a debate in dosing regimen, specially regarding dose interval, with a potential lower bioavalability in once daily regimens. The aim of this study is to assess the acute effects of carvedilol posology in patients with clinically significant portal hypertension (CSPH), as a surrogate marker of bioavailability.
In this experimental study, patients with CSPH receiving carvedilol twice daily were asked to supress the night dose of carvedilol, in order to have a dose interval of approximately 24 hours. Spleen stiffness measurement (SSM) by transient elastography (TE) was performed and compared with SSM prior or under treatment. Same procedure was applied to liver stiffness measurement (LSM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with CSPH (defined as a LSM 25 kPa or SSM over 45kPa prior to introduction of carvedilol)
排除标准
- •Non-responders to non-selective β-blockers (NSBB)
- •NSBB other than carvedilol
- •Dosing regimen other than twice daily
- •No SSM or LSM within 3 months prior to the beginning of the study
- •Body mass index (BMI) > 30 m/kg2
- •Contraindications to NSBB use
- •Portal venous thrombosis
- •Refusal to participate in the study
- •Failure to comply to the study regimen
研究组 & 干预措施
Patients with CSPH receiving carvedilol twice daily and supress the night dose of carvedilol
In this experimental study, 34 patients with CSPH receiving carvedilol twice daily were asked to supress the night dose of carvedilol, in order to have a dose interval of approximately 24 hours. Spleen stiffness measurement (SSM) by transient elastography (TE) was performed and compared with SSM prior or under treatment. Same procedure was applied to liver stiffness measurement (LSM).
干预措施: supress the night dose of carvedilol (Drug)
结局指标
主要结局
spleen stiffness measurement (SSM)
时间窗: Baseline SSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol
Change from baseline in spleen stiffness measurement (SSM) measured by transient elastography (TE) after 24 hour suspension of carvedilol treatment.
次要结局
- liver stiffness measurement (LSM)(Baseline LSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol)
研究者
Bruno Besteiro
MD, Principal Investigator
Centro Hospitalar De São João, E.P.E.