5-HT3 Antagonists (Antiemetics) and Cardiac Safety

NCT02436798 | Completed

• 1 other identifier: H13-02338
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adverse Reaction to Other Drugs and Medicines

Keywords

QT prolongation; Genomic biomarkers

Outcome Measures

Primary Outcomes (1)

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

  Up to 2 years

Study Arms (2)

Pediatric patients

Children \<6 months to 18 years of age receiving ondansetron for management of: 1. Post-operative nausea and vomiting 2. Chemotherapy-induced nausea and vomiting

Drug: Ondansetron

Female patients

Pregnant patients or women of a reproductive age (18-45 years) receiving ondansetron for management of: 1. Hyperemesis gravidarum 2. Post-operative nausea and vomiting

Drug: Ondansetron

Interventions

Ondansetron DRUG

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

Also known as: Zofran

Female patients; Pediatric patients

Eligibility Criteria

• Age: 6 Months - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children, women of a reproductive age, and pregnant women receiving ondansetron for treatment of post-operative or chemotherapy-induced nausea and vomiting or hyperemesis gravidarum.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

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

Vancouver, British Columbia, V6H 3V4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples will be retained for genomic analyses.

MeSH Terms

Conditions

Long QT Syndrome

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Bruce Carleton, PharmD.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pharmaceutical Outcomes Programme

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: May 7, 2015
• Study Start: June 1, 2014
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

CA (1)