Hydroxyzine and Risk of Prolongation of QT Interval

NCT02814981 | Unknown DMC

• 1 other identifier: A15-D44-VOL.27
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydroxyzine; Long QT Syndrome

Keywords

hydroxyzine; Long QT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Incoming of torsade de pointe

  up to 1 month

• risk of sudden death by ventricular arythmia

  up to 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Unstable Patient hospitalized in an intensive care unit or intensive care.
• Patient refusing participation in the study.
• Age \<18 years old.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Alexandre Joachim

Caen, Basse Normandie, 14000, France

RECRUITING

MeSH Terms

Conditions

Long QT Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 28, 2016
• Study Start: November 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 28, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)