Hydroxyzine and Risk of Prolongation of QT Interval (HYDROXYZINE-QT)

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 Overview

• Status: Unknown
• Conditions: Long QT Syndrome; Hydroxyzine

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• France
  • Basse Normandie
    • Caen, Basse Normandie, France, 14000
      • Recruiting
      • Alexandre Joachim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All Patients hospitalized in Caen University Hospital with a prescription of hydroxyzine drug.

From there, after informing the patient, we will collect the measurement of QT interval before introducing hydroxyzine and the same measure will be performed again on the 3rd day.

QT will be corrected by heart rate by Bazett's formula (the most commonly used) and Fridericcia (most reliable). Reproducibility of analyzes inter and intra-individual will be carried out to ensure the reliability of the measurements.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
risk of sudden death by ventricular arythmia		up to 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: hydroxyzine; Long QT
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Long QT Syndrome
• Other Study ID Numbers: A15-D44-VOL.27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes