QT prolongation when using domperidone: prevalence and associated risk factors

Withdrawn

• Conditions: cardiac dysrhythmia; QT prolongation; 10007521

• Registration Number: NL-OMON40915
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 300

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is QTc-time on ECG, performed 30-60 minutes after the fourth<br /><br>dosage of domperidone (or later, when necessary, but never earlier due to<br /><br>steady state). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- QTc trended over a 24-hour period in the subsample of the study population.<br /><br>- QTc difference from baseline (defined as the QTc time at start of the 24 hour<br /><br>period), trended over a 24-hour period<br /><br>- Occurence of arrthymias (Torsade de Pointes and VT/VF)<br /><br>- blood level of domperidone<br /><br>- pharmacogenetic profile<br /><br><br /><br><br /><br>A number of potential risk factors (among which blood level and pharmacogenetic<br /><br>profile) will be collected, for which the association with QT prolongation will<br /><br>be determined.</p><br>