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临床试验/NCT02814981
NCT02814981Unknown不适用

Hydroxyzine and Risk of Prolongation of QT Interval

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
130
试验地点
1
主要终点
Measure of the corrected QT interval in ms

研究概览

简要总结

On 04/30/2015, ANSM (the National Security Agency of Medicines and Health Products) shared an information for general practicioners, pediatricians, anesthesiologists, dermatologists, geriatricians, psychiatrists, community pharmacists and hospital about using hydroxyzine and the associated risk of QT prolongation on the electrocardiogram.

Drugs containing hydroxyzine (the best known and most used is the Atarax®) are used in France in various indications including the treatment of minor manifestations of anxiety, premedication with general anesthesia and the symptomatic treatment of urticaria.

A prolonged QT interval is a known risk factor for occurrence of torsades de pointes which can cause sudden death. We distinguish congenital and acquired long QT interval. The main cause of acquired long QT interval is a drug inhibition of the HERG potassium channel 1. Many drugs have been reported to cause sudden death by prolongation of QT interval and occurrence of torsades de pointes (macrolides, anti -arythmics, some psychotropic ...) The molecules based on hydroxyzine are known to be at risk of prolongation of QT interval in an experimental point of view but is not clearly identified in daily clinical practice. Pharmacology unit of Caen was the first to publish a case of QT prolongation under hydroxyzine . Through this publication, associated with other clinical data, hydroxyzine has been added to the list of drugs that can induce QT prolongation .

Despite these recent recommendations, it does not seem that hydroxyzine prescriptions were changed daily and therefore the risk of QT prolongation persists. We therefore propose the study of the impact of hydroxyzine on the QT interval measured on the electrocardiogram in patients hospitalized at the University Hospital of Caen.

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

入选标准

  • Patients hospitalized at the University Hospital of Caen with a new prescription of oral hydroxyzine by their referring doctor.
  • Patient 'stable' in hospital in a health service or surgery.
  • Age > 18 years old.

排除标准

  • Unstable Patient hospitalized in an intensive care unit or intensive care.
  • Patient refusing participation in the study.
  • Age <18 years old.

结局指标

主要结局

Measure of the corrected QT interval in ms

时间窗: 1 day

Measure of corrected QT interval with Bazett and Frediriccia method , in DII and V5.

次要结局

  • risk of sudden death by ventricular arythmia(up to 1 year)
  • Number of Incoming of torsade de pointe(up to 1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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