Suspended

HYDROXYZINE-QTHydroxyzine and Risk of Prolongation of QT Interval

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Congenital Abnormalities+8

+ Cardiac Conduction System Disease

+ Arrhythmias, Cardiac

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2015
See protocol details

Summary

Principal SponsorUniversity Hospital, Caen
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2015

Actual date on which the first participant was enrolled.

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.

Official TitleHydroxyzine and Risk of Prolongation of QT Interval
NCT02814981
Principal SponsorUniversity Hospital, Caen
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesCardiac Conduction System DiseaseArrhythmias, CardiacCardiovascular DiseasesHeart Defects, CongenitalHeart DiseasesLong QT SyndromeCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiovascular Abnormalities

Criteria

3 inclusion criteria required to participate
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.

3 exclusion criteria prevent from participating
Unstable Patient hospitalized in an intensive care unit or intensive care.

Patient refusing participation in the study.

Age <18 years old.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Alexandre Joachim

Caen, FranceOpen Alexandre Joachim in Google Maps
SuspendedOne Study Center
HYDROXYZINE-QT | Hydroxyzine and Risk of Prolongation of QT Interval | PatLynk