QT-prolongation in Psychiatric Hospitals

• Sponsor: KU Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT02043925
• Collaborator: Agentschap voor Innovatie door Wetenschap en Technologie (Other)
• Enrollment: 152
• Location: 1
• Duration (Months): 53
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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	Phase
QT-prolongation	Drug: drugs linked with QT-prolongation

Study Design

• Study Type: Observational
• Actual Enrollment: 152 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: QT-prolongation in Psychiatric Hospitals
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatrisch Centrum Sint-Jan	Eeklo		Belgium

Sponsors and Collaborators

• KU Leuven
• Agentschap voor Innovatie door Wetenschap en Technologie

Investigators

• Principal Investigator: Eline Vandael, PhD-student, KU Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eline Vandael, PhD-student, KU Leuven
• ClinicalTrials.gov Identifier: NCT02043925
• Other Study ID Numbers: VF/2010/02
• First Posted: Jan 23, 2014
• Last Update Posted: Jul 28, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Eline Vandael, PhD-student, KU Leuven: QT-prolongation; Torsade de Pointes; drug interactions; psychiatry
• Additional relevant MeSH terms: Long QT Syndrome

Study Results

No Results Posted as of Jul 28, 2015