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

NCT06268535 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36580288

Last updated 2025-01-31

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268535 on ClinicalTrials.gov