Long QT Syndrome Clinical Trial
— HYDROXYZINE-QTOfficial title:
Hydroxyzine and Risk of Prolongation of QT Interval
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.
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Alexandre Joachim | Caen | Basse Normandie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
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 |
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