NCT02043925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

4.4 years

First QC Date

January 21, 2014

Last Update Submit

July 27, 2015

Conditions

QT-prolongation

Keywords

QT-prolongationTorsade de Pointesdrug interactionspsychiatry

Outcome Measures

Primary Outcomes (1)

  • change in QTc-interval (corrected for heart rate)

    before and one week after the start of a QT-prolonging drug

Study Arms (1)

psychiatric patients treated with QT-prolonging drugs

Drug: drugs linked with QT-prolongation

Interventions

drugs linked with QT-prolongationDRUG

all the drugs that are mentioned in the lists of QT-prolonging drugs of CredibleMeds (www.crediblemeds.org)

psychiatric patients treated with QT-prolonging drugs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • age \< 18 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatrisch Centrum Sint-Jan

Eeklo, Belgium

Location

MeSH Terms

Conditions

Long QT SyndromeTorsades de Pointes

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardia, VentricularTachycardia

Study Officials

  • Eline Vandael, PhD-student

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-student

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 23, 2014

Study Start

October 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

BE(1)