Hydroxyzine and Risk of Prolongation of QT Interval

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2017

Clinical Trial Outcome Measures

Primary Measures

  • Measure of the corrected QT interval in ms
    • Time Frame: 1 day
    • Measure of corrected QT interval with Bazett and Frediriccia method , in DII and V5.

Secondary Measures

  • Number of Incoming of torsade de pointe
    • Time Frame: up to 1 month
    • polymorphic ventricular tachycardia with a characteristic illusion of a twisting of the QRS complex
  • risk of sudden death by ventricular arythmia
    • Time Frame: up to 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • 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. Exclusion Criteria:
  • Unstable Patient hospitalized in an intensive care unit or intensive care. – Patient refusing participation in the study. – Age <18 years old.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University Hospital, Caen
    • Provider of Information About this Clinical Study
      • Sponsor

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.