QT-prolongationNCT02043925
QT-prolongation in Psychiatric Hospitals
An observational study of QT-prolongation, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- QT-prolongation
- What is being tested?
- drugs linked with QT-prolongation
- How many people
- 152 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2010to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- inpatient in one of the 6 participating psychiatric hospitals
- QT-prolonging drug in the medication profile and the doctor prescribes another QT-prolonging drug
Who cannot join
- age < 18 year
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- QT-prolongation
- Being tested
- drugs linked with QT-prolongation
- Keywords
- QT-prolongation, Torsade de Pointes, drug interactions, psychiatry
- Medical subject headings
- Long QT Syndrome, Torsades de Pointes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drugs linked with QT-prolongationDrug
all the drugs that are mentioned in the lists of QT-prolonging drugs of CredibleMeds (www.crediblemeds.org)
| Study group | Role | What they receive |
|---|---|---|
| psychiatric patients treated with QT-prolonging drugs | Not described Receives: Drug: drugs linked with QT-prolongation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in QTc-interval (corrected for heart rate)
Measured: before and one week after the start of a QT-prolonging drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startOct 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QT-prolongationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Responsible party
- Principal investigator, Eline Vandael, KU Leuven
- Investigators
- Eline Vandael, PhD-student, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043925
- Sponsor's protocol ID
- VF/2010/02
- Status last verified
- Jul 2015
- First submitted
- 21 Jan 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QT-prolongation in Psychiatric Hospitals
- ClinicalTrials.gov ID
- NCT02043925
- Acronym / sponsor ID
- VF/2010/02
- Conditions
- QT-prolongation
- Keywords
- QT-prolongation, Torsade de Pointes, drug interactions, psychiatry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Oct 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| psychiatric patients treated with QT-prolonging drugs | – | Drug: drugs linked with QT-prolongation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- inpatient in one of the 6 participating psychiatric hospitals
- QT-prolonging drug in the medication profile and the doctor prescribes another QT-prolonging drug
Key exclusion criteria (1 listed)
- age < 18 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drugs linked with QT-prolongationall the drugs that are mentioned in the lists of QT-prolonging drugs of CredibleMeds (www.crediblemeds.org) | Drug | psychiatric patients treated with QT-prolonging drugs |
Primary outcome
change in QTc-interval (corrected for heart rate)
Time frame: before and one week after the start of a QT-prolonging drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eline Vandael, PhD-student principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of QT-prolongation, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in QTc-interval (corrected for heart rate) (time frame: before and one week after the start of a QT-prolonging drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.