To assess the prevalence of QTc-prolongation in patients who are prescribed two or more QTc-prolongating drugs as part of usual care, and to assess potential risk factors for that QTc-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 at the moment of tmax of the
lastly added drug (or in case of starting at the same time, at the moment of
the longest tmax).
Secondary outcome
Potential risk factors for QTc time prolongation. The following parameters will
be collected as potential risk factors for QTc prolongation:
- General patient characteristics: age, gender, race, bodyweight, length,
comorbidities, liver function parameters, renal function parameters, serum
electrolyte parameters
- Dosage of the interacting drugs
- Comedication
- Blood concentration levels of the interacting drugs, when these have been
determined.
- Pharmacogenetic parameters when these have been determined.
Background summary
Several drugs have been shown to cause QTc prolongation and sudden cardiac
death and the risk increases when such drugs are combined. However, the exact
magnitude of the problem is unknown making it difficult for doctors to
interpret the drug-drug interaction alert on QTc-time prolongation. Therefore,
doctors need additional information on the actual prevalence of
QTc-prolongation in everyday routine practice, as well as on risk factors
associated with QTc-prolongation when combining two or more QTc-prolongating
drugs. Such information will guide safe prescription practices and may assist
in the development of a clinical rule, facilitating the correct handling of
this drug-drug interaction alert.
Study objective
To assess the prevalence of QTc-prolongation in patients who are prescribed two
or more QTc-prolongating drugs as part of usual care, and to assess potential
risk factors for that QTc-prolongation.
Study design
Observational study
Study burden and risks
For each patient an ECG will be performed. All drugs are only given as part of
routine usual care, so no pharmacotherapeutical interventions are carried out.
In case a clinically relevant QTc-prolongation is discovered, the doctor of the
patient will we adviced to switch to another drug regimen. The doctor will also
be informed about any other cardiac dysrhythmias discovered on the ECG.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Using a combination of two or more QTc-time prolongating drugs (either already in use before hospitalization or newly started).
Exclusion criteria
- Not providing informed consent
- Incompetent
- Terminally ill
- Congenital prolonged QTc-syndrome
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53580.078.15 |