5-HT3 Antagonists (Antiemetics) and Cardiac Safety

5-HT3 antagonists (ondansetron) are highly effective medications for the treatment of nausea and vomiting. However, these medications also associated with potentially severe and life-threatening cardiac adverse drug reactions (ADRs), particularly QT prolongation. Data regarding the cardiac safety and inter-individual variability in cardiac effects of ondansetron when used in vulnerable populations such as children and pregnant women are very limited. The results of this study will enable better-informed therapeutic decision-making regarding the use of ondansetron in children and pregnant women, with the overall goal to improve the safety of these commonly used antiemetic medications. Furthermore, predictive pharmacogenetic markers of severe 5-HT3 antagonist toxicity could be used to identify patients at risk of cardiac toxicity before the drug is administered.

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Key information

Conditions

Adverse Reaction to Other Drugs and Medicines 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

Age range

6 month–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's and Women's Health Centre of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

About this study

The specific objectives are to:

Determine and compare the cardiac safety profile of ondansetron in children, when used for prevention and management of post-operative nausea and vomiting and chemotherapy induced nausea and vomiting. Identify clinical factors including pre-existing cardiac conditions or physiological conditions that predispose to ventricular arrhythmias, concomitant cardiotoxic chemotherapy or concomitant volatile anaesthetic agents and investigate their impact on cardiac adverse effects of ondansetron.
Determine and compare the cardiac safety profile of ondansetron when used in pregnant women or women of a reproductive age for the treatment of hyperemesis gravidarum or post-operative nausea and vomiting. Identify clinical factors including pre-existing cardiac conditions or physiological conditions, which predispose to ventricular arrhythmias that may support implementation of risk mitigation actions.
Identify genetic variants associated with 5-HT3 antagonist-induced prolongation of QT interval.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Children 6 months - 18 years of age who are being treated with ondansetron for prevention and management of post-operative nausea and vomiting and chemotherapy-induced nausea and vomiting.
Pregnant women and women of a reproductive age (18-45 years of age) who are being treated with ondansetron for hyperemesis gravidarum or postoperative nausea and vomiting.

Exclusion criteria

Patients with congenital long QT syndrome.
Subjects who do not speak and understand English.

Treatment and study plan

ondansetron

Drug

All patients will be receiving treatment with ondansetron as part of standard care.

Other names: Zofran

Primary outcomes

Identify clinical and genetic variants associated with ondansetron-induced prolongation of QT interval

Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

5-HT3 Antagonists (Antiemetics) and Cardiac Safety Using an Active Surveillance Approach

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: May 7, 2015
Registry last updated: May 14, 2021

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.

Published trials that share one or more normalized conditions with this study.

Completed