To assess the prevalence of QT-prolongation in patients who are prescribed domperidone as part of usual care, and to assess potential risk factors for that QT-prolongation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is QTc-time on ECG, performed 30-60 minutes after the fourth
dosage of domperidone (or later, when necessary, but never earlier due to
steady state).
Secondary outcome
- QTc trended over a 24-hour period in the subsample of the study population.
- QTc difference from baseline (defined as the QTc time at start of the 24 hour
period), trended over a 24-hour period
- Occurence of arrthymias (Torsade de Pointes and VT/VF)
- blood level of domperidone
- pharmacogenetic profile
A number of potential risk factors (among which blood level and pharmacogenetic
profile) will be collected, for which the association with QT prolongation will
be determined.
Background summary
Domperidone has been shown to cause QT prolongation and sudden cardiac death.
On the other hand, domperidone is still needed as an effective antiemetic,
especially in patients with Parkinson*s disease. Therefore, doctors need
additional information on the actual prevalence of QT-prolongation in everyday
routine practice, as well as on risk factors associated with QT-prolongation.
Such information will guide safe prescription practices.
Study objective
To assess the prevalence of QT-prolongation in patients who are prescribed
domperidone as part of usual care, and to assess potential risk factors for
that QT-prolongation.
Study design
Observational study
Study burden and risks
For each patient one blood sample will be drawn (30-60 minutes after the fourth
dosage of domperidone; necessary for serum level and for pharmacogenetics) and
an ECG will be performed (at the same time). A small sample of patients will be
monitored with a 24 hour ECG monitor.
Domperidone is only given as part of routine usual care, so no
pharmacotherapeutical interventions are carried out. In case a clinically
relevant QT-prolongation is discovered, the doctor of the patient will we
adviced to switch to another antiemetic drug. The doctor will also be informed
about any other cardiac dysrhythmias discovered on the ECG. Finally, the doctor
will be informed on pharmacogenetic disorders.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Starting with domperidone while in hospital (patients already on domperidone when admitted to hospital, may be included as well)
Exclusion criteria
- Not providing informed consent
- Incompetent
- Terminally ill
- Congenital prolonged QT-syndrome
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-001769-29-NL |
| CCMO | NL49083.078.14 |
| OMON | NL-OMON28199 |