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Trial record 28 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

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

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ClinicalTrials.gov Identifier: NCT02814981
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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.


Condition or disease
Hydroxyzine Long QT Syndrome

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hydroxyzine and Risk of Prolongation of QT Interval
Study Start Date : November 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : October 2017





Primary Outcome Measures :
  1. Measure of the corrected QT interval in ms [ Time Frame: 1 day ]
    Measure of corrected QT interval with Bazett and Frediriccia method , in DII and V5.


Secondary Outcome Measures :
  1. Number of Incoming of torsade de pointe [ Time Frame: up to 1 month ]
    polymorphic ventricular tachycardia with a characteristic illusion of a twisting of the QRS complex

  2. risk of sudden death by ventricular arythmia [ Time Frame: up to 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814981


Locations
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France
Alexandre Joachim Recruiting
Caen, Basse Normandie, France, 14000
Contact: Joachim Alexandre, MD       alexandre-j@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02814981     History of Changes
Other Study ID Numbers: A15-D44-VOL.27
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University Hospital, Caen:
hydroxyzine
Long QT

Additional relevant MeSH terms:
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Long QT Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes
Hydroxyzine
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs