Hydroxyzine and Risk of Prolongation of QT Interval

Long QT Syndrome Clinical Trial

— HYDROXYZINE-QT  

Official title:

Hydroxyzine and Risk of Prolongation of QT Interval

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02814981
• Other study ID #: A15-D44-VOL.27
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2016
• Last updated: June 23, 2016
• Start date: November 2015
• Est. completion date: October 2017

Study information

• Verified date: June 2016
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hydroxyzine
• Long QT Syndrome

Locations

Country	Name	City	State
France	Alexandre Joachim	Caen	Basse Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of the corrected QT interval in ms	Measure of corrected QT interval with Bazett and Frediriccia method , in DII and V5.	1 day	No
Secondary	Number of Incoming of torsade de pointe	polymorphic ventricular tachycardia with a characteristic illusion of a twisting of the QRS complex	up to 1 month	No
Secondary	risk of sudden death by ventricular arythmia		up to 1 year	No