Hydroxyzine and Risk of Prolongation of QT Interval (HYDROXYZINE-QT)
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|ClinicalTrials.gov Identifier: NCT02814981|
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Caen.
Recruitment status was: Recruiting
First Posted : June 28, 2016
Last Update Posted : June 28, 2016
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.
|Condition or disease|
|Hydroxyzine Long QT Syndrome|
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||Hydroxyzine and Risk of Prolongation of QT Interval|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||October 2017|
- 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.
- 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 ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814981
|Caen, Basse Normandie, France, 14000|
|Contact: Joachim Alexandre, MD email@example.com|