QT-prolongationNCT02043912
Drug Interactions With Risk of QT-prolongation in a General Hospital
An observational study of QT-prolongation, run by KU Leuven at 1 site in Belgium.
Trial summary
In this epidemiological point prevalence study, medication profiles of patients with haloperidol treatment will be checked for drug interactions with risk of QT-prolongation. Additional clinical risk factors for developing QT-prolongation and safety measurements will be documented. 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?
- Haloperidol
- How many people
- 222 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2013to Apr 2014
- 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: patients who are treated with haloperidol (every tuesday we will make a selection of the patients who received haloperidol on monday)
Who may be able to join
- treatment with haloperidol (started in the hospital)
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Interactions With Risk of QT-prolongation in a General Hospital: an Epidemiological Point Prevalence Study
In this epidemiological point prevalence study, medication profiles of patients with haloperidol treatment will be checked for drug interactions with risk of QT-prolongation. Additional clinical risk factors for developing QT-prolongation and safety measurements will be documented.
Read the detailed description
Study design: epidemiological point prevalence study
Target population: Patients with haloperidol treatment
The following aspects will be investigated:
- The medication profiles will be checked for drug interactions with risk of QT-prolongation.
- Clinical risk factors for developing QT-prolongation (gender, age, (history of) cardiovascular disease, comorbidity,...) and lab results will be collected.
- Safety measurements (e.g. ECG) will be documented.
- Conditions
- QT-prolongation
- Being tested
- Haloperidol
- Keywords
- QT-prolongation, Torsade de Pointes, Haloperidol, Drug interactions
- 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.
HaloperidolDrug
Also called Haldol
| Study group | Role | What they receive |
|---|---|---|
| patients treated with haloperidol | Not described Receives: Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc-interval (corrected for heart rate)
Measured: maximum one year before inclusion / one week after inclusion
Secondary outcomes (1)
number of drug interactions (with risk of QT-prolongation)
Measured: one week before/after inclusion
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 startJul 2013
- Primary completionFeb 2014
- Study completionApr 2014
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.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- 222 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
- NCT02043912
- Sponsor's protocol ID
- EV002
- Status last verified
- Jun 2014
- First submitted
- 21 Jan 2014
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Interactions With Risk of QT-prolongation in a General Hospital: an Epidemiological Point Prevalence Study
- ClinicalTrials.gov ID
- NCT02043912
- Acronym / sponsor ID
- EV002
- Conditions
- QT-prolongation
- Keywords
- QT-prolongation, Torsade de Pointes, Haloperidol, Drug interactions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (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.
In this epidemiological point prevalence study, medication profiles of patients with haloperidol treatment will be checked for drug interactions with risk of QT-prolongation. Additional clinical risk factors for developing QT-prolongation and safety measurements will be documented.
Detailed description
Study design: epidemiological point prevalence study
Target population: Patients with haloperidol treatment
The following aspects will be investigated:
- The medication profiles will be checked for drug interactions with risk of QT-prolongation.
- Clinical risk factors for developing QT-prolongation (gender, age, (history of) cardiovascular disease, comorbidity,...) and lab results will be collected.
- Safety measurements (e.g. ECG) will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients treated with haloperidol | – | Drug: Haloperidol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are treated with haloperidol (every tuesday we will make a selection of the patients who received haloperidol on monday)
Key inclusion criteria (1 listed)
- treatment with haloperidol (started in the hospital)
Key exclusion criteria (1 listed)
- age < 18 years
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 |
|---|---|---|
| HaloperidolAlso: Haldol | Drug | patients treated with haloperidol |
Primary outcome
QTc-interval (corrected for heart rate)
Time frame: maximum one year before inclusion / one week after inclusion
1 secondary outcome
number of drug interactions (with risk of QT-prolongation)
Time frame: one week before/after inclusion
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 11 Jun 2014.
Related trials for QT-prolongation
Active, not recruitingPhase 1/2
Opt-IVF for Personalized Medicine for Normal Responders
Ivf
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Active, not recruitingObservational study
Observational Study to Describe Health-Related Quality of Life and Measure Disease Burden Among Patients With Long QT Syndrome Types (LQTS) 2 and 3
Long QT Syndrome Type 3, Long QT Syndrome 2
Not yet recruitingObservational study
Physical Activity and Functional Capacity in Patients With Congenital Long QT Syndrome
Long QT Syndrome, Channelopathies
Recruiting
Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders
ICSI, IVF
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 1 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 11 Jun 2014. 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?
QTc-interval (corrected for heart rate) (time frame: maximum one year before inclusion / one week after inclusion). 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 11 Jun 2014.