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Trial record 23 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

QT-prolongation in Psychiatric Hospitals

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ClinicalTrials.gov Identifier: NCT02043925
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : July 28, 2015
Sponsor:
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
Eline Vandael, KU Leuven

Brief Summary:
Observational study in 6 psychiatric hospitals in Flanders. Patients are included when a QT-prolonging drug is added to a medication profile that already contains a potential QT-prolonging drug. An ECG is taken before the administration of the new drug and a week after starting the new drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation and blood concentrations of potassium and creatinine are documented.

Condition or disease Intervention/treatment
QT-prolongation Drug: drugs linked with QT-prolongation

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Study Type : Observational
Actual Enrollment : 152 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: QT-prolongation in Psychiatric Hospitals
Study Start Date : October 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Group/Cohort Intervention/treatment
psychiatric patients treated with QT-prolonging drugs Drug: drugs linked with QT-prolongation
all the drugs that are mentioned in the lists of QT-prolonging drugs of CredibleMeds (www.crediblemeds.org)




Primary Outcome Measures :
  1. change in QTc-interval (corrected for heart rate) [ Time Frame: before and one week after the start of a QT-prolonging drug ]


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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
Observational study in 6 psychiatric hospitals in Flanders. Patients are included when a QT-prolonging drug is added to a medication profile that already contains a potential QT-prolonging drug.
Criteria

Inclusion Criteria:

  • inpatient in one of the 6 participating psychiatric hospitals
  • QT-prolonging drug in the medication profile and the doctor prescribes another QT-prolonging drug

Exclusion Criteria:

  • age < 18 year

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): NCT02043925


Locations
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Belgium
Psychiatrisch Centrum Sint-Jan
Eeklo, Belgium
Sponsors and Collaborators
KU Leuven
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
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Principal Investigator: Eline Vandael, PhD-student KU Leuven

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Responsible Party: Eline Vandael, PhD-student, KU Leuven
ClinicalTrials.gov Identifier: NCT02043925     History of Changes
Other Study ID Numbers: VF/2010/02
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Eline Vandael, KU Leuven:
QT-prolongation
Torsade de Pointes
drug interactions
psychiatry

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