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

Completed

• Conditions: Heart Failure; Cancer, Therapy-Related

• Registration Number: NCT06268535
• Lead Sponsor: University Hospital, Caen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36580288

Inclusion Criteria

• Case reported in the World Health Organization (WHO) database of individual safety case reports to 29/02/2024
• Patients treated with FDA and/or EMA approved cancer therapies (approval the 30th September 2023).

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies	Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024	A disproportionality analysis is carried out using stepwise selection procedure and taking into account confounding factors (factors known to promote heart failure or cardiac dysfunction).

Secondary Outcome Measures

Name	Time	Method
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed	Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024
Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies	Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024	The investigators describe the profile of cases of heart failure of cardiac dysfunction among cancer therapies associated with heart failure or cardiac dysfunction in the main analysis. We particularly focused on factors known to promote heart failure.
Description of the drug-drug interactions associated with adverse events	Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France