QT-prolongation in Psychiatric Hospitals | NCT02043925

Studies
QT-prolongation in Psychiatric Hospitals

NCT02043925

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Jul 28, 2015Estimated

Enrollment

152Actual

Phase

Not provided

Conditions

QT-prolongation

Interventions

drugs linked with QT-prolongation

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jan 21, 2014

First Submission Date that Met QC Criteria

Jan 21, 2014

First Posted Date

Jan 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2015

Last Update Posted Date

Jul 28, 2015Estimated

Name	Class
Agentschap voor Innovatie door Wetenschap en Technologie	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

152Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
psychiatric patients treated with QT-prolonging drugs			Drug: drugs linked with QT-prolongation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
drugs linked with QT-prolongation	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in QTc-interval (corrected for heart rate)		before and one week after the start of a QT-prolonging drug

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eline Vandael, PhD-student	KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Psychiatrisch Centrum Sint-Jan		Eeklo			Belgium

Condition Browse Module

MeSH Terms

ID	Term
D008133	Long QT Syndrome
D016171	Torsades de Pointes

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease

Browse Leaves

Not provided

Browse Branches

Not provided