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Completed

NCT Number: NCT02043912

Drug Interactions With Risk of QT-prolongation in a General Hospital

In this epidemiological point prevalence study, medication profiles of patients with haloperidol treatment will be checked for drug interactions with risk of QT-prolongation. Additional clinical risk factors for developing QT-prolongation and safety measurements will be documented.

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Key information

Conditions

QT-prolongation Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Long QT Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Torsades de Pointes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

About this study

Study design: epidemiological point prevalence study

Target population: Patients with haloperidol treatment

The following aspects will be investigated:

  • The medication profiles will be checked for drug interactions with risk of QT-prolongation.
  • Clinical risk factors for developing QT-prolongation (gender, age, (history of) cardiovascular disease, comorbidity,...) and lab results will be collected.
  • Safety measurements (e.g. ECG) will be documented.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • treatment with haloperidol (started in the hospital)

Exclusion criteria

  • age < 18 years

Treatment and study plan

Haloperidol

Drug

Other names: Haldol

Primary outcomes

  1. QTc-interval (corrected for heart rate)

    Time frame: maximum one year before inclusion / one week after inclusion

Secondary outcomes

  1. number of drug interactions (with risk of QT-prolongation)

    Time frame: one week before/after inclusion

Other outcomes

  1. number of patients with an ECG before or after the start of haloperidol

    Time frame: maximum one year before inclusion / one week after inclusion

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

Registry information

Official study title

Drug Interactions With Risk of QT-prolongation in a General Hospital: an Epidemiological Point Prevalence Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2014
Registry last updated
Jun 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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