QTc-time prolongation when using two or more QTc-time prolongating drugs: prevalence and associated risk factors

QTc-time prolongation when using two or more QTc-time prolongating drugs: prevalence and associated risk factors - QTc-time when using two or more QTc-prolongators (QT-INTERACT)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42786

Enrollment

500

Registered

2015-07-31

Start date

2015-09-23

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

heart rhythm disorders QTc time prolongation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Not providing informed consent - Incompetent - Terminally ill - Congenital prolonged QTc-syndrome

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results