QTc-prolongation due to combinations of drugs - a prospective study with a focus on pharmacokinetic and pharmacogenetic risk factors

QTc-prolongation due to combinations of drugs - a prospective study with a focus on pharmacokinetic and pharmacogenetic risk factors - QTc-prolongation due to combinations of drugs

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30361

Enrollment

3000

Registered

2006-11-01

Start date

2007-01-16

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart rhythm disturbances QTc-prolongation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients for whom a combination of 2 or more QTc-interval prolonging drugs have been prescribed.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The primary outcome is the incidence of prolonged QTc-interval during use of all combinations of QTc-interval prolonging drugs	—

Secondary

Measure	Time frame
1. Are drug concentrations in patients with clinically significant prolongation of the QTc-interval higher compared to patients without prolongation of the QTc-interval? 2. For the pharmacogenetic analysis we will compare the presence of variant alleles, as dichotomic variabele, in both groups with the *2-test.	—

Countries

Netherlands

Outcome results