NCT06268535

Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a Pharmacovigilance Study

Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a WHO Pharmacovigilance Database

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36,580,288 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy. Among these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death. Patients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. It is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions. The explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction. Using VigiBase, the World Health Organization's (WHO) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs.

Conditions

• Heart Failure
• Cancer, Therapy-Related

Interventions

Type	Name	Description
DRUG	Cancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023	Disproportionality analysis studying the association between cancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023 and heart failure or cardiac dysfunction in the World Health Organization pharmacovigilance database.

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2024-02-20
• Last updated: 2025-01-31

Locations

1 site across 1 country: France