QTc-prolongation due to combinations of drugs - a prospective study with a focus on pharmacokinetic and pharmacogenetic risk factors
Completed
- Conditions
- heart rhythm disturbancesQTc-prolongation10007521
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3000
Inclusion Criteria
All patients for whom a combination of 2 or more QTc-interval prolonging drugs have been prescribed.
Exclusion Criteria
No written informed consent obtained.
Patients in whom life expectancy or clinical situation is such that a risk of heart rhythm disturbances is irrelevant to clinical care.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the incidence of prolonged QTc-interval during use of<br /><br>all combinations of QTc-interval prolonging drugs </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Are drug concentrations in patients with clinically significant prolongation<br /><br>of the QTc-interval higher compared to patients without prolongation of the<br /><br>QTc-interval?<br /><br>2. For the pharmacogenetic analysis we will compare the presence of variant<br /><br>alleles, as dichotomic variabele, in both groups with the *2-test. </p><br>