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Hydroxyzine and Risk of Prolongation of QT Interval

Hydroxyzine and Risk of Prolongation of QT Interval

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02814981
Acronym
HYDROXYZINE-QT
Enrollment
130
Registered
2016-06-28
Start date
2015-11-30
Completion date
2017-10-31
Last updated
2016-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydroxyzine, Long QT Syndrome

Keywords

hydroxyzine, Long QT

Brief 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.

Interventions

None listed

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Measure of the corrected QT interval in ms1 dayMeasure of corrected QT interval with Bazett and Frediriccia method , in DII and V5.

Secondary

MeasureTime frameDescription
Number of Incoming of torsade de pointeup to 1 monthpolymorphic ventricular tachycardia with a characteristic illusion of a twisting of the QRS complex
risk of sudden death by ventricular arythmiaup to 1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026